Physical Activity Counselling for Young Adult Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Adherence rates
研究概览
简要总结
Survival rates for cancer are increasing, resulting in more young adult cancer survivors living with lingering side effects. Physical activity has been shown to improve the quality and length of life in young adult cancer survivors; yet, few are active enough, and little is currently being done to promote physical activity in this population. The investigators developed a novel behaviour support intervention to promote physical activity in young adult cancer survivors. In this two-arm pilot randomized controlled trial, the investigators aim to: (1) assess trial and intervention feasibility, (2) assess trial and intervention acceptability, and (3) generate data on physical activity behaviour. Young adult cancer survivors will be randomized to receive either a 12-week behaviour support intervention delivered via videoconferencing or will be allocated to usual care.
详细描述
Background: Young adults commonly experience persistent side effects following cancer treatment that impair quality of life. Physical activity (PA) holds promise as an intervention to mitigate persistent side effects and improve quality of life. Yet, few young adults are active enough to incur these benefits and efforts to promote PA following cancer treatment are lacking. Therefore, the investigators developed a novel behaviour support intervention to promote PA in young adults following cancer treatment, and have undertaken a pilot randomized controlled trial (RCT) to determine whether the intervention delivered via videoconferencing is both feasible and acceptable. Specifically, the aims of this ongoing parallel group two-arm pilot RCT are to: (1) assess trial and intervention feasibility and acceptability, and (2) generate data on PA behaviour.
Methods: Young adults who have completed cancer treatment are recruited from across Canada. Recruits are randomized to the intervention group (IG; i.e., a 12-week behaviour support intervention delivered via videoconferencing) or usual care (UC; no intervention). Drawing on the CONSORT 2010 statement and flow diagram, several feasibility outcomes pertaining to enrolment, allocation, follow-up, and analysis are tracked by study staff. Acceptability is assessed through interviews exploring IG and UC participants' experiences, thoughts, and perspectives of the trial, IG participants' views of the intervention and its mode of delivery, and PA counsellors' experiences delivering the intervention. PA is measured using accelerometers. Assessments take place at baseline (pre-randomization), post-intervention period, and at follow-up (24 weeks post-baseline).
Discussion: Feasibility and acceptability data will help determine if/what changes/modifications are needed to improve the trial protocol and/or intervention, and will inform the timeline for a definitive RCT. The PA behaviour data collected will inform sample size calculation for a future RCT that aims to test the effects of this intervention in young adults following cancer treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently between the ages of 18-39 years;
- •Received a first diagnosis of invasive cancer between the ages of 18-39 years;
- •Completed primary treatment for cancer <5 years;
- •Able to provide informed consent in English or French;
- •Have approval of a healthcare provider to participate in the trial;
- •Have access to videoconferencing technology (e.g., Skype, Google Hangouts, FaceTime).
排除标准
- •Have evidence of current cancer (recurrent or secondary cancer or relapse);
- •Currently meeting the Canadian Society for Exercise Physiology aerobic physical activity guidelines for cancer survivors in the month prior to enrolment (i.e., 150 minutes/week of moderate-to-vigorous intensity aerobic physical activity);
- •Are non-ambulatory.
结局指标
主要结局
Adherence rates
时间窗: Duration of study (24 months)
The number of intervention sessions attended out of the total recommended as part of the intervention
Data completeness: Quantitative measures
时间窗: Duration of study (24 months)
The percentage of missing data on quantitative measures.
Recruitment rates
时间窗: Duration of study (24 months)
The number of eligible participants who enrol in the trial out of the number who are referred
Retention rates
时间窗: Duration of study (24 months)
The number of participants completing all three scheduled assessments.
Acceptability of the trial and intervention
时间窗: At week 12
Participants will be asked to share their experiences, thoughts, and perspectives of the trial, the physical activity counsellor and the intervention by responding to open and close-ended questions during a semi-structured interview. Responses to close-ended questions will range from 1 ('poor' or 'not satisfied at all') to 10 ('excellent' or 'extremely satisfied').
Data completeness: Qualitative interviews
时间窗: Duration of study (24 months)
The number of participants completing the acceptability interview following the intervention.
次要结局
- Depressive symptoms: Patient Health Questionnaire Depression Scale (PHQ-9; Kroenke, Spitzer & Williams, 2001)(Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24))
- Health-related quality of life: RAND 36-Item Short Form Health Survey (SF-36; Ware & Sherbourne, 1992)(Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24))
- Autonomy support, structure and interpersonal involvement: Health Care Climate Questionnaire (Marcus et al., 1992)(Post-intervention (week 12))
- Impact of cancer: Impact of Cancer Instrument - Adolescent and Young Adult Module (Husson & Zebrack, 2017)(Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24))
- Physical activity behaviour: 7-day accelerometer wear (objective physical activity behaviour)(Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24))
- Positive and negative affect: Positive and Negative Affect Schedule (PANAS-SF; Watson, Clark & Tellegen, 1998)(Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24))
- Anxiety symptoms: 7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7; Kroenke, Spitzer & Williams, 2006)(Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24))
- Basic psychological need satisfaction in relation to physical activity: Psychological Need Satisfaction in Exercise Scale (PNSE; Wilson, Rogers & Rodgers, 2006)(Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24))
- Motivation for physical activity: Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3; Markland & Tobin, 2004)(Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24))
研究者
Jennifer Brunet
Associate professor
University of Ottawa