Development and pilot testing of a psychoeducational intervention for oral cancer patients

OBJECTIVE: Oral cancer elicits considerable distress in both the pre and post-treatment periods. This paper details the development, validation and pilot-testing of a psychoeducational intervention for oral cancer patients. METHOD: An educational booklet covering information about oral cancer and its treatment and effective coping strategies was developed by a multi-disciplinary team. It was evaluated by patient focus groups and content/educational experts, delivered to subjects in pre and post-operative presentations by a health educator, and pilot-tested in a randomized controlled trial versus standard care. RESULTS: Pilot data from 19 subjects (10 psychoeducation, nine standard care) indicates that the intervention is feasible and highly acceptable. At follow-up the intervention group showed a gain in knowledge, less body image disturbance, lower anxiety and a trend toward higher wellbeing. CONCLUSION: This program, which is currently being evaluated in a larger RCT with extended follow-up, should prove useful in reducing the psychosocial burden of oral cancer and its treatment.     

Feasibility study on quality-of-life questionnaires for patients with advanced lung cancer.

In order to evaluate quality-of-life (QOL) questionnaires, we studied the reliability and validity of the self-rating forms: A, comprising 16 questions; B, comprising 39 questions (Table II and III), in a special study supported by the Ministry of Health and Welfare. Sixty-four patients with inoperable lung cancer and 50 patients with chronic, non-malignant disease were entered into the study. Form A was translated and modified to Japanese culture from Schipper's Functional Living Index-Cancer, and Form B was of our own design. The internal consistency of the forms was examined by Cronbach's alpha coefficient. Both forms except for aspects of physical and social concern on form B, had alpha values greater than 0.65. A concurrent validity with performance status was shown over all aspects of concern (Pearson's correlation, r greater than 0.27, P less than 0.05) except for social (forms A and B) and psychological (form B). Analysis of variance of the QOL scores revealed significantly lower scores for the cancer patients than for the non-malignant-disease patients, except for the social aspect of concern (P less than 0.001). Factor analysis, using the principal component method, identified four major factors to account for 60 and 42% of the total variance on forms A and B, respectively. The factors were: patient's mood, anxiety over disease and treatment, relationships with other people, physical capability. In conclusion, this has been the first feasible study to show that QOL forms from the West could be used in Japan with some modifications. We are at present studying successive changes in QOL for advanced lung cancer patients in clinical trials.     

Feasibility of intravenous gemcitabine and an intraperitoneal platinum agent in the treatment of ovarian cancer

The goal of this study is to determine the feasibility of intravenous gemcitabine and an intraperitoneal platinum agent in the treatment of patients with ovarian cancer. We performed a retrospective chart review of patients with primary, persistent or recurrent ovarian cancer, who received intravenous gemcitabine and an intraperitoneal platinum agent. Patients received gemcitabine (750 mg/m2) intravenous on days 1 and 8 and cisplatin (100 or 60 mg/m2) intraperitoneal on day 1 every 21 - 28 days. An alternate regimen was composed of gemcitabine (750 mg/m2) intravenous and carboplatin (AUC 5) intraperitoneal on day 1 every 21 days. Dose reductions occurred at the discretion of the prescribing physician.Intravenous gemcitabine and an intraperitoneal platinum agent were administered to 12 patients with advanced primary or recurrent ovarian cancer. Myelosuppression was the most common toxicity. Grade 3 or 4 thrombocytopenia, neutropenia and anemia occurred in 7, 8 and 2 patients respectively. Dose reductions were required in 7 of 12 patients. 10 of 12 patients received 6 cycles of the regimen. Treatment was discontinued prior to 6 cycles in 2 of 12 patients secondary to progression in one case and to grade 4 neutropenia and thrombocytopenia in another.The combination of intravenous gemcitabine and an intraperitoneal platinum agent appears to be a feasible regimen in patients with ovarian cancer. The most common toxicity was myelosuppression, which resulted in dose reductions in almost half of the patients.     

A randomised controlled trial of a psychoeducational intervention for women at increased risk of breast cancer

This study aimed to compare the impact of two versions of a psychoeducational written intervention on cancer worry and objective knowledge of breast cancer risk-related topics in women who had been living with an increased risk of familial breast cancer for several years. Participants were randomised to three conditions: scientific and psychosocial information pack (Group 1), scientific information pack only (Group 2) or standard care control (Group 3). They completed postal questionnaires at baseline (n=163) and 4 weeks (n=151). As predicted, there was a significant decrease in cancer worry for Group 1, but not Group 2. Objective knowledge significantly improved for both Group 1 and Group 2 as expected, but not Group 3. However, there was an unpredicted decline in cancer worry for Group 3. This study supports the value of a scientific and psychosocial information pack in providing up-to-date information related to familial risk of breast cancer for long-term attendees of a familial breast cancer clinic. Further research is warranted to determine how the information pack could be incorporated into the existing clinical service, thus providing these women with the type of ongoing psychosocial support that many familial breast cancer clinics are currently lacking.     

Feasibility of group intervention for bereaved siblings after pediatric cancer death

This study evaluated the feasibility (acceptability, recruitment, retention rates, treatment fidelity, and outcome measures) of implementing a manualized group intervention for bereaved siblings after pediatric cancer death. A convenience sample of 10 siblings participated. The intervention consisted of eight 2-hour sessions that focused on strategies for coping with grief, relationships, and emotional growth. Positive outcomes were obtained with respect to acceptability, recruitment, retention rates, and treatment fidelity. Preliminary outcomes were mixed. Parent pre- and post-intervention outcomes suggested improvements in siblings' overall emotional and social quality of life. Siblings' self-reports reflected no improvements. These data support the feasibility of conducting this intervention and suggest beneficial outcomes based on parental reports. Further research is recommended to evaluate the group intervention efficacy with a large sample using a randomized controlled trial to address the needs of bereaved siblings.     

Feasibility of an expressive-disclosure group intervention for post-treatment colorectal cancer patients: results of the Healthy Expressions study

BACKGROUND:

Adjusting to cancer requires effective cognitive and emotional processing. Written and verbal disclosure facilitate processing and have been studied independently in cancer survivors. Combined written and verbal expression may be more effective than either alone, particularly for patients with difficult to discuss or embarrassing side effects. Thus, the authors developed and tested the efficacy of a 12‐session combined written and verbal expression group program for psychologically distressed colorectal cancer (CRC) patients.

METHODS:

Forty post‐treatment patients with CRC (stages I‐III) identified as psychologically distressed using the Brief Symptom Inventory (BSI) were randomized to an intervention group (Healthy Expressions; n = 25) or standard care (control group; n = 15). Assessments were completed at baseline, Month 2, and Month 4 (postintervention). Primary outcomes were psychological functioning and quality of life (QOL).

RESULTS:

Most participants were women (63%), white (63%), and non‐Hispanic (75%). The Healthy Expressions group demonstrated significantly greater changes in distress compared with the control group at Month 2 on the BSI Global Severity Index (GSI) and the Centers for Epidemiologic Studies Depression scale (CES‐D) scores (P < .05 for each); differences in the European Organization for Research and Treatment of Cancer (EORTC) global QOL scores approached significance (P = .063). The BSI GSI and Positive Symptom Total, CES‐D, and EORTC emotional functioning subscale scores were all significant at Month 4 (P < .05 for each).

CONCLUSIONS:

The Healthy Expressions program improved psychological functioning in CRC patients who reported experiencing distress. Findings demonstrate the program's feasibility and provide strong support for conducting a larger randomized trial. Cancer 2011;. © 2011 American Cancer Society.     

Feasibility of a multidisciplinary intervention to help cancer patients return to work

This study evaluates feasibility of a multidisciplinary intervention combining occupational counselling with physical exercise to enhance cancer patients’ return to work, assesses whether care providers and patients were satisfied with the intervention, and describes barriers to and facilitators of execution. Newly diagnosed cancer patients, treated with chemotherapy and on sick leave from (self‐)employment participated. Patients received counselling from an oncological occupational physician (OOP), were assessed by a sports physician, and performed a 12‐week training programme supervised by physiotherapists. Care providers completed registration forms to collect data on reach, dose delivered and received in executing the protocol and were interviewed about their satisfaction and barriers to and facilitators of execution. Patients completed three questionnaires on satisfaction and usefulness of the intervention. Fifty‐six per cent of all patients were eligible (reach). In total, 123 patients participated. For all intervention components dose delivered exceeded 75%; dose received ranged from 49%–79%. Overall, patients and care providers were satisfied and perceived the intervention as useful. Care providers considered the intervention feasible, while execution was facilitated by highly motivated patients and impeded by physical limitations hindering exercise. It is feasible to conduct this multidisciplinary intervention in cancer patients during curative treatment. Patients and care providers were satisfied with the intervention.     

Can unorthodox cancer therapy improve quality-of-life?

The introduction of a psychosocial component into quality-of-lifescores in cancer patients means that any belief which increaseshope of cure on benefit will improve the score, and may overrideadverse physical components of the measurement. Such a beliefmay be the denial of a bad prognosis by some patients. Therecan be no objection to the patient seeking the temporary reassurancewhich may come from unorthodox therapies, as long as they areharmless and do not interfere with orthodox therapy. They maygive the patient with a bad prognosis the necessary time todevelop inner strengths enabling him to come to terms with thesituation quality-of-life, unorthodox cancer therapy, alternative therapy, complementary therapy     

Feasibility of implementing an exercise intervention in older adults with hematologic malignancy

Older adults with Hematologic Malignancy (HM) are vulnerable to functional decline secondary to disease and treatment. Interventions for physical deconditioning, in concert with routine hematology care are limited. The feasibility of accrual, retention, and demand for an exercise intervention among a high-risk HM population was piloted.MethodsOlder adults with HM, on active treatment, with functional impairment were recruited prospectively to participate in a 6-month Otago Exercise Programme (OEP). Measures of motivation, self-efficacy, patient identified barriers to exercise, barriers to clinical trial enrollment, study satisfaction, and serious adverse events were captured.Results63 patients were approached, 18 declined trial enrollment, 45 consented, 30 patients enrolled in the exercise program. The main barrier for trial enrollment was transportation/travel concerns (n = 15). Of the 45 consented participants, 8 (12.7%) dropped out due to clinical deterioration, 5 (7.9%) withdrew, and 2 (3.2%) were ineligible prior to exercise-intervention intiation. The median age was 75.5 years (range 62–83) with plasma cell dyscrasia (63%), non-Hodgkin lymphoma (20%) and leukemia (17%). Retention of the physical therapist (PT) led-OEP was 76.6% of patients (n = 23/30), and end-of-study retention was 66.7% (n = 20/30). Of the evaluable patients, 23/29 completed the PE-led OEP yielding a completion rate of 79%. Participants were extremely motivated (72.4%) and strongly intended (89.7%) to engage in regular physical activity. Exercising when tired increased from a median score of 50 at Visit 1 to 70 at Visit 2, but dropped significantly to 45 at Visit 3 (p < 0.001). Participants reported significantly lower self-efficacy to exercise over the next 6 months from Visit 1 to Visit 3 (p = 0.001).ConclusionsOlder patients with HM had higher completion of in-person, PT-led exercise compared to at-home, independent exercise. Older adults were motivated and found the program acceptable, yet the ability to sustain a structured exercise program was challenging due to changes in health status.ClinicalTrials.gov Identifier: NCT02791737     

Feasibility of an exercise rehabilitation programme for cancer patients

A growing body of evidence indicates the benefits of exercise as a rehabilitation intervention for cancer patients. However, few hospitals offer exercise-based rehabilitation programmes to patients. This study evaluated the feasibility and acceptability of a group-based exercise programme for cancer patients attending a local oncology centre. The intervention consisted of a weekly instructor-led circuit training class supplemented by home-based activity 4 days/week for 10 weeks. From 28 eligible patients, 12 were recruited (43%), of whom nine completed the intervention (75%). The three withdrawals were due to worsening of disease. Adherence (mean of 7.5 classes attended and 4 days/week of home activity performed) and tolerability (no adverse events) were good. Positive features of the programme identified in interviews with participants included the variety and scope of the exercises, and the empathetic but positive approach of the instructors. The small group format was highly valued with participants receiving social support and inspiration from each other. Perceived outcomes included improved fitness, reduced fatigue, enjoyment, enhanced mood and a sense of achievement. Several participants felt that the intervention represented a stepping stone to becoming habitual exercisers. Results suggested that the programme was feasible and acceptable to patients, but uptake was low, indicating a need for more effective recruitment strategies in order for a cost-effective service to be implemented.     

Feasibility and outcome of complete secondary tumor resection for patients with advanced ovarian cancer

From November 1981 to July 1985, 124 women with International Federation of Gynecology and Obstetrics (FIGO) stage III ovarian cancer were treated in prospective studies of surgery and chemotherapy in our institution. Patients with no macroscopic cancer after primary surgery (n = 16) received five cycles of adjuvant cis-platinum; those with residual cancer after primary laparotomy (n = 108) underwent a second surgical debulking after three or five cycles of cis-platinum-based cytoreductive chemotherapy. Total macroscopic tumor clearance was achieved in 26 of these 108 patients. Fourteen patients with total tumor excision at primary laparotomy remain in complete clinical remission a minimum of 36 months after diagnosis, but the median progression-free interval for the other two groups was 9 and 17 months, respectively. The survival for women who have total tumor clearance only at secondary surgery after chemotherapy is inferior to that for women with primary macroscopic tumor excision followed by chemotherapy.     

Feasibility and preliminary efficacy of an exercise telephone counseling intervention for hematologic cancer survivors: a phase II randomized controlled trial

Background

Supervised exercise interventions produce the largest improvements in patient-reported outcomes in cancer survivors but their scalability has been questioned. Telephone counseling has been proposed as a more feasible alternative but its impact on exercise behavior and health outcomes have been modest. Basing telephone counseling exercise (TCE) interventions on the theoretical advances described in the multi-process action control framework (M-PAC) may improve these outcomes.

Purpose

To assess the feasibility and preliminary efficacy of a M-PAC-based TCE intervention for increasing aerobic exercise behavior in hematologic cancer survivors (HCS).

Methods

We recruited 51 HCS who were randomized to either a weekly TCE group (n?=?26) or a self-directed exercise (SDE) group (n?=?25). Participants completed online measures of self-reported aerobic exercise behavior, quality of life (QoL), fatigue, and program satisfaction at baseline and post-intervention (12 weeks).

Results

Adherence to the TCE intervention was 93% and retention was 100%. Participants receiving TCE increased their weekly aerobic exercise by 218 min compared to 93 min in the SDE group [mean-adjusted between-group difference (MBGD_adj)?=?139, 95%CI?=?65 to 213, p?<?.001, effect size (d)?=?2.19]. Clinically meaningful QoL improvements favored the TCE group for mental health (MBGD_adj?=?3.7, 95%CI?=???0.4 to 7.9, p?=?.08, d?=?0.42) and mental health component (MBGD_adj?=?3.6, 95%CI?=???0.8 to 8.1, p?=?.10, d?=?0.35) subscales.

Conclusions

The 12-week TCE intervention substantially increased exercise behavior and may have meaningfully improved QoL in HCS.

Implications for Cancer Survivors

Though more definitive trials are needed, remote TCE interventions based on the M-PAC may improve exercise behavior and QoL in HCS and perhaps other cancer survivor groups.

Trial registration number

Clinical Trials ID: NCT03052777

     

Docetaxel: an alternative taxane in ovarian cancer

The taxanes paclitaxel and docetaxel are potent chemotherapeutic agents that block tubulin depolymerisation, leading to the inhibition of microtubule dynamics and cell cycle arrest. Although docetaxel and paclitaxel share a mutual tubulin binding site, mechanistic and pharmacological differences exist between these agents. For example, docetaxel has increased potency and an improved therapeutic index compared with paclitaxel, and its short 1-h infusion offers a substantial clinical advantage over the prolonged infusion durations required with paclitaxel. In clinical studies, docetaxel monotherapy demonstrated good response rates and an acceptable toxicity profile in both paclitaxel- and platinum-refractory ovarian cancer patients. In particular, neurotoxicity - a dominant side effect with both paclitaxel and cisplatin - occurs at a low incidence with docetaxel, making docetaxel a promising agent for combining cisplatin and other platinum compounds. In Phase II studies, the combination of docetaxel with either cisplatin or carboplatin has yielded impressive response rates of 69-74 and 81-87%, respectively. Furthermore, Phase III data suggest that docetaxel-carboplatin and paclitaxel-carboplatin are similarly efficacious with respect to progression-free survival and clinical response, although neurotoxicity occurs more frequently with the paclitaxel regimen. While paclitaxel-carboplatin remains the standard treatment for the management of advanced ovarian cancer, docetaxel-carboplatin appears to be a promising alternative, particularly in terms of minimising the incidence and severity of peripheral neuropathy.     

Intraperitoneal chemotherapy in ovarian cancer: an update

Based on the poor 5-year survival rates for advanced ovarian cancer, novel therapies are needed. Because ovarian cancer largely is confined to the peritoneal cavity for much of its natural history, the intraperitoneal administration of chemotherapy is a biologically rationale and novel approach to the delivery of chemotherapy. Interest in intraperitoneal therapy as first-line therapy has been rekindled by three large randomized clinical trials, which have demonstrated improved median overall survival rates. This article reviews these trials and addresses areas of concern and the need for additional trials.     

Planning and reporting of quality-of-life outcomes in cancer trials

BackgroundInformation about the impact of cancer treatments on patients' quality of life (QoL) is of paramount importance to patients and treating oncologists. Cancer trials that do not specify QoL as an outcome or fail to report collected QoL data, omit crucial information for decision making. To estimate the magnitude of these problems, we investigated how frequently QoL outcomes were specified in protocols of cancer trials and subsequently reported.DesignRetrospective cohort study of RCT protocols approved by six research ethics committees in Switzerland, Germany, and Canada between 2000 and 2003. We compared protocols to corresponding publications, which were identified through literature searches and investigator surveys.ResultsOf the 173 cancer trials, 90 (52%) specified QoL outcomes in their protocol, 2 (1%) as primary and 88 (51%) as secondary outcome. Of the 173 trials, 35 (20%) reported QoL outcomes in a corresponding publication (4 modified from the protocol), 18 (10%) were published but failed to report QoL outcomes in the primary or a secondary publication, and 37 (21%) were not published at all. Of the 83 (48%) trials that did not specify QoL outcomes in their protocol, none subsequently reported QoL outcomes. Failure to report pre-specified QoL outcomes was not associated with industry sponsorship (versus non-industry), sample size, and multicentre (versus single centre) status but possibly with trial discontinuation.ConclusionsAbout half of cancer trials specified QoL outcomes in their protocols. However, only 20% reported any QoL data in associated publications. Highly relevant information for decision making is often unavailable to patients, oncologists, and health policymakers.