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

     

Adherence to a randomized controlled trial of aerobic exercise in breast cancer survivors: the Yale exercise and survivorship study

Purpose  To examine predictors of exercise adherence in breast cancer survivors. Methods  Seventy-five breast cancer survivors were randomly assigned to exercise (n = 37) or usual care (n = 38). Demographic, prognostic, physiologic, and psychosocial information was collected at baseline and 6 months. The exercise goal was 30 min of exercise 5 days/week for 6 months. Results  Women randomized to exercise participated in moderate-intensity recreational exercise for 123 ± 52 min/week (81% of the prescribed 150 min/week) over 6 months. Baseline variables associated with better adherence were lower body mass index (BMI), smaller waist circumference, higher amounts of physical activity 6 months prior to enrollment, being in the preparation vs. contemplation Stage of Change and higher FACT-B breast cancer subscale score. After adjusting for these variables, lower BMI and higher Stage of Change continued to be associated with better adherence (p < 0.05). Conclusions  Future studies of exercise and breast cancer prognosis should target obese women for participation, as well as women just beginning to contemplate participation and its benefits after a cancer diagnosis.     

Randomized controlled trial of a clinic-based survivorship intervention following adjuvant therapy in breast cancer survivors

In 2006, the IOM released a report citing the importance of “survivorship plans” to improve quality of life and care coordination for cancer survivors, but little has been done to evaluate their efficacy. Women with early-stage breast cancer were randomized within 6 weeks of completing adjuvant therapy to a survivorship intervention group (SI) or control group (CG). All subjects were given the NCI publication, “Facing Forward: Life after Cancer Treatment.” The SI also met with a nurse/nutritionist to receive a treatment summary, surveillance, and lifestyle recommendations. Both groups completed questionnaires on the impact of cancer (IOC), patient satisfaction (FACIT-TS-PS), and assessment of survivor concerns (ASC) at baseline, 3 and 6 months. Within and between group t tests and linear regression analyses were performed. Among 126 women (60 CG, 66 SI), mean age was 54 years, 48 % were Hispanic, and the groups were well-balanced by baseline characteristics. No significant differences between the CG and SI on the FACIT-TS-PS or IOC at 3 and 6 months were seen. The ASC health worry subscale was lower (less worry) in the SI compared to CG (p = 0.02). At all time-points, Hispanic women had higher (worse) health worry (p = 0.0008), social-life interference (p = 0.009), and meaning of cancer scales (p = 0.0004), and more trust in medical professionals (p = 0.03) compared to non-Hispanic women. While the SI did not lead to significant improvements in most patient-reported outcomes, it was associated with decreased health worry. Future interventions should determine the most efficient and effective method for delivering survivorship care plans.     

Feasibility and preliminary efficacy of progressive resistance exercise training in lung cancer survivors

Lung cancer survivors exhibit poor functional capacity, physical functioning, and quality of life (QoL). Here, we report the feasibility and preliminary efficacy of a progressive resistance exercise training (PRET) intervention in post-treatment lung cancer survivors. Seventeen post-treatment lung cancer survivors (10 female), with a mean age of 67 (range 50-85), mean BMI of 25, and diagnosed with non-small cell lung cancer (94%) were recruited in Edmonton, Canada between August 2009 and August 2010 to undergo PRET. The primary outcomes focused on feasibility including eligibility and recruitment rate, loss to follow-up, measurement completion, exercise adherence, and program evaluation. Secondary outcomes addressed preliminary efficacy and included changes in muscular strength (1 repetition maximum), muscular endurance (repetitions at 70% of 1 repetition maximum), body composition (DXA scan), physical functioning (6-minute-walk-test, up-and-go, sit-to-stand, arm curls), and patient-reported outcomes including QoL (SF-36, FACT-L), fatigue (FACT-F), dyspnea (MRCD), and patient-rated function (LLFI). Forty of 389 lung cancer survivors were eligible (10%) and 17 of the 40 (43%) were recruited. Over 80% of participants were able to complete all testing; two participants were lost to follow-up, and the median adherence rate was 96% (range: 25-100%). Ratings of testing burden were low (i.e., less than two out of seven for all items), and trial evaluation was high (i.e., greater than six out of seven for all measures). Paired t-tests showed significant increases in muscular strength (p < .001), muscular endurance (p < .001), six-minute walk distance (p < .001), up-and-go time (p < .05), number of arm curls (p < .001), and number of chair stands (p < .001). There were no significant changes in body composition or patient-reported outcomes. PRET is a feasible intervention with potential health benefits for a small proportion of lung cancer survivors in the post-treatment setting.     

Randomised controlled trial of a supervised exercise rehabilitation program for colorectal cancer survivors immediately after chemotherapy: study protocol

Background  

Colorectal cancer (CRC) diagnosis and the ensuing treatments can have a substantial impact on the physical and psychological health of survivors. As the number of CRC survivors increases, so too does the need to develop viable rehabilitation programs to help these survivors return to good health as quickly as possible. Exercise has the potential to address many of the adverse effects of CRC treatment; however, to date, the role of exercise in the rehabilitation of cancer patients immediately after the completion of treatment has received limited research attention. This paper presents the design of a randomised controlled trial which will evaluate the feasibility and efficacy of a 12-week supervised aerobic exercise program (ImPACT Program) on the physiological and psychological markers of rehabilitation, in addition to biomarkers of standard haematological outcomes and the IGF axis.     

Randomized trial of a clinic-based weight loss intervention in cancer survivors

Background

This trial examined the efficacy of a clinic-based weight loss intervention in cancer survivors.

Methods

This single-center phase II trial randomized survivors of solid tumors and hematologic malignancies to a 15-week group-based weight loss intervention that included caloric restriction and physical activity (n = 30) or a wait-list control intervention (n = 30). The primary study outcome was body mass. Secondary study outcomes included body composition using dual-energy X-ray absorptiometry, physical fitness using the 6-min walk test (6MWT), and concentrations of serum biomarkers.

Results

Participants in the intervention group lost 5.6 ± 4.4% of baseline weight (4.6 ± 3.9 kg), whereas participants in the control group gained 0.2 ± 2.4% of baseline weight (0.2 ± 2.0 kg); intervention effect ? 5.8% (95% CI ? 7.8, ? 3.8); ? 4.8 kg (95% CI ? 6.6, ? 3.0); P = 0.0001. A larger proportion of participants in the intervention group lost ≥ 5% of baseline weight compared to the control group (43 vs 0%; P < 0.0001). The intervention led to reductions in fat mass (? 3.2 ± 0.7 kg; P < 0.0001), improvements in physical fitness (an increase of 22.6 ± 10.8 m on 6MWT; P = 0.03), and reductions in concentrations of insulin (? 7.7 ± 3.5 μU/mL; P = 0.004) and leptin (? 7.3 ± 4.0 ng/mL; P = 0.04).

Conclusion

A 15-week clinic-based weight loss intervention resulted in significant weight loss and improvements in body composition, physical fitness, and concentrations of serum biomarkers in cancer survivors.

Implications for cancer survivors

Weight loss programs provide a number of benefits for cancer survivors; survivors should inquire about the availability of lifestyle programs offered at their cancer center and within their local communities.

     

Recruitment and retention challenges in breast cancer survivorship research: results from a multisite, randomized intervention trial in women with early stage breast cancer.

The Moving Beyond Cancer trial is a multisite randomized, controlled trial of an individualized psychoeducational intervention for women with early stage breast cancer. Recruitment early in the cancer trajectory and assessment of retention at multiple points are notable features of the research, offering a unique opportunity to examine recruitment, retention, and predictors of participation. Patients were registered for the study within 6 weeks after definitive surgery and followed until primary medical treatment completion, whereupon they were enrolled, administered baseline measures, and randomized to one of three arms. Of 2,242 women referred, 41% were ineligible. Of eligible women, 42% elected participation through the point of randomization (n = 558). Participants did not differ from nonparticipants on initial self-reported physical functioning and mental health status, employment status, cancer history, cancer treatment plan, or previous cancer-related research participation. Women who were over 65 years of age, of racial minority status, unmarried, or less educated were less likely to participate through the point of randomization. Thus, several patient characteristics predicted trial participation, indicating the need for targeted recruitment attempts.     

美国癌症幸存者和肿瘤患者生存状况研究简介

癌症幸存者（又可译为癌症生存者）是指长期生存的癌症患者。随着肿瘤诊断、治疗技术的不断进展和新型药 物的出现,肿瘤患者长期生存已经成为现实。但是,在抗肿瘤治疗过程中和治疗结束以后,以及日后的随访和监测复发中, 癌症幸存者们在生理、心理、经济和社会各方面都有着特殊的困难。这些困难包括各种抗肿瘤疗法导致的长期毒副作用和 后遗症的管理;从肿瘤患者向癌症幸存者角色的转变;从以治疗为主向以保健养生为主的转变;以及个人、社会和家庭角 色正常化的重新适应。此外,肿瘤专科医生和社区家庭医师也对癌症幸存者的特殊需求缺乏了解和专业训练。过去三十 年来,越来越多的研究揭示了癌症幸存者的特殊需求。当前,一个针对癌症幸存者的新兴医学研究和服务领域已经在欧 美国家兴起：肿瘤患者生存状况研究和服务。这个领域涉及多学科专业人员、政府组织、社会团体、肿瘤患者和家属的共 同关注和参与。癌症幸存者的生存状态服务已经成为肿瘤专科和其他医学专科的重点之一。本文对美国癌症幸存者及其生 存状况的定义、历史发展和现状进行了回顾分析,同时本文也结合中国肿瘤患者的现状,对在中国开展肿瘤患者生存状况 研究和服务提出了建议和展望。     

Predictors of adherence and contamination in a randomized trial of exercise in colorectal cancer survivors

The purpose of this study was to examine predictors of exercise adherence (i.e. exercise in the intervention group) and exercise contamination (i.e. exercise in the control group) in a randomized controlled trial of home-based exercise in colorectal cancer survivors. At baseline, 102 participants completed measures of the theory of planned behavior, personality, past exercise, exercise stage of change, physical fitness, and medical/demographics and then were randomly assigned in a 2:1 ratio to an exercise (n=69) or control (n=33) group. Exercise was monitored weekly for 16 weeks using self-reports by telephone. Ninety-three (91%) participants completed the trial. Adherence was 76% in the exercise group and contamination was 52% in the control group. Hierarchical stepwise regression analyses indicated that baseline exercise stage of change (beta=0.35; p=0.001), employment status (beta=-0.28; p=0.010), treatment protocol (beta=-0.26; p=0.018), and perceived behavioral control (beta=0.20; p=0.055) explained 39.6% of the variance in exercise adherence. Intentions (beta=0.36; p=0.049) and baseline exercise stage of change (beta=0.30; p=0.095) explained 29.9% of the variance in exercise contamination. These findings may have implications for conducting clinical trials of exercise in colorectal cancer survivors and for promoting exercise to colorectal cancer survivors outside of clinical trials.     

Feasibility and efficacy of a remotely delivered fall prevention exercise program for community-dwelling older adults with cancer: Protocol for the STABLE trial

Falls are a major issue in older adults with cancer due to the effects of cancer and its treatments. Ample evidence in the general population of older adults has demonstrated the effectiveness of strength and balance training in reducing fall rates in older adults. However, data on effective fall prevention interventions in the oncology setting are lacking. The objective of this study is to evaluate the feasibility and efficacy of a remotely delivered, partially-supervised, resistance and balance training program on lower body strength, balance, and falls in community-dwelling older adults with cancer. The proposed study is an observer-blinded, parallel group (intervention group vs. control group) randomized controlled trial (ClinicalTrials.gov Identifier: NCT04518098). This study will recruit 74 eligible community-dwelling older adults with cancer from a comprehensive cancer centre. Intervention includes a remotely delivered exercise program for 3 months. Outcome measures include feasibility measures, lower body strength, balance, and fall rates. Research ethics approval has been granted by the Biomedical Research Ethics Boards of the University of Saskatchewan. If found effective, findings from this study will inform a subsequent, phase III definitive trial, with the ultimate goal to reduce falls and reduce impact on cancer treatment. Study findings will be disseminated through presentation at community level and scientific conferences, and in scientific journals.Trial registration: ClinicalTrials.gov identifier: NCT04518098     

A person-centered intervention targeting the psychosocial needs of gynecological cancer survivors: a randomized clinical trial

Purpose

We investigated the effect of a person-centered intervention consisting of two to four nurse-led conversations using guided self-determination tailored to gynecologic cancer (GSD-GYN-C) on gynecological cancer survivors’ quality of life (QOL), impact of cancer, distress, anxiety, depression, self-esteem, and self-reported ability to monitor and respond to symptoms of recurrence.

Methods

We randomly assigned 165 gynecological cancer survivors to usual care (UC) plus GSD-GYN-C or UC alone. Self-reported QOL-cancer survivor (QOL-CS) total score and subscale scores on physical, psychological, social, and spiritual well-being were assessed before randomization and at 3 and 9 months after randomization using t tests. Bonferroni and Pipper corrections were applied for multiple testing adjustments.

Results

At 9 months, the GSD-GYN-C plus UC group scored significantly higher on the QOL-CS total scale (P?=?0.02) and on the QOL-CS physical well-being subscale (P?=?0.01), compared to women receiving UC alone. After adjusting for baseline scores, only the difference in the physical well-being subscale was statistically significant. No other measured outcomes differed between the intervention and control groups after baseline adjustment.

Conclusion

We observed higher physical well-being 9 months after randomization in the GSD-GYN-C group, as compared to women receiving usual care.

Implications for Cancer Survivors

The results suggest that the person-centered intervention GSD-GYN-C may improve physical well-being in gynecological cancer survivors. However, further testing is needed.

     

Move More for Life: The protocol for a randomised efficacy trial of a tailored-print physical activity intervention for post-treatment breast cancer survivors

ABSTRACT: BACKGROUND: Due to early detection and advances in treatment, the number of women surviving breast cancer is increasing. Whilst there are many positive aspects of improved survival, breast cancer survival is associated with many long-term health and psychosocial sequelae. Engaging in regular physical activity post-diagnosis can reduce this burden. Despite this evidence, the majority of breast cancer survivors do not engage in regular physical activity. The challenge is to provide breast cancer survivors with appealing and effective physical activity support in a sustainable and cost-effective way. This article describes the protocol for the Move More for Life Study, which aims to assess the relative efficacy of two promising theory-based, print interventions designed to promote regular physical activity amongst breast cancer survivors. Method and design: Breast cancer survivors were recruited from across Australia. Participants will be randomised into one of three groups: (1) A tailored-print intervention group, (2) a targeted-print intervention group, or (3) a standard recommendation control group. Participants in the tailored-print intervention group will recieve 3 tailored newsletters in the mail over a three month period. Participants in the targeted-print group will receive a previously developed physical activity guidebook designed specifically for breast cancer survivors immediately after baseline. Participants in the standard recommendation control will receive a brochure detailing the physical activity guidelines for Australian adults. All participants will be assessed at baseline, and at 4 and 10 months post-baseline. Intervention efficacy for changing the primary outcomes (mins/wk aerobic physical activity; sessions/exercises per week resistance physical activity) and secondary outcomes (steps per day, health-related quality life, compliance with physical activity guidelines, fatigue) will be assessed. Mediation and moderation analyses will also be conducted. DISCUSSION: Given the growing number of cancer survivors, distance-based behaviour change programs addressing physical activity have the potential to make a significant public health impact.