Clinical trial NCT04163042: Physical Activity Counselling for Young Adult Cancer Survivors
Official title: Physical Activity Counselling for Young Adult Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Survivorship
Cancer
Keywords: Physical activity
Behavioural support
Oncology
Telehealth
Self-determination theory
Behaviour change techniques
Young adult cancer survivors
Lead sponsor: University of Ottawa
Sponsor class: OTHER
First posted: 2019-11-14
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Recruitment rates
timeFrame: Duration of study (24 months)
measure: Adherence rates
timeFrame: Duration of study (24 months)
measure: Acceptability of the trial and intervention
timeFrame: At week 12
measure: Retention rates
timeFrame: Duration of study (24 months)
measure: Data completeness: Quantitative measures
timeFrame: Duration of study (24 months)
measure: Data completeness: Qualitative interviews
timeFrame: Duration of study (24 months)
Secondary outcomes:
measure: Physical activity behaviour: 7-day accelerometer wear (objective physical activity behaviour)
timeFrame: Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24)
measure: Health-related quality of life: RAND 36-Item Short Form Health Survey (SF-36; Ware & Sherbourne, 1992)
timeFrame: Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24)
measure: Positive and negative affect: Positive and Negative Affect Schedule (PANAS-SF; Watson, Clark & Tellegen, 1998)
timeFrame: Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24)
measure: Depressive symptoms: Patient Health Questionnaire Depression Scale (PHQ-9; Kroenke, Spitzer & Williams, 2001)
timeFrame: Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24)
measure: Anxiety symptoms: 7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7; Kroenke, Spitzer & Williams, 2006)
timeFrame: Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24)
measure: Impact of cancer: Impact of Cancer Instrument - Adolescent and Young Adult Module (Husson & Zebrack, 2017)
timeFrame: Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24)
measure: Motivation for physical activity: Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3; Markland & Tobin, 2004)
timeFrame: Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24)
measure: Basic psychological need satisfaction in relation to physical activity: Psychological Need Satisfaction in Exercise Scale (PNSE; Wilson, Rogers & Rodgers, 2006)
timeFrame: Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24)
measure: Autonomy support, structure and interpersonal involvement: Health Care Climate Questionnaire (Marcus et al., 1992)
timeFrame: Post-intervention (week 12)
Other outcomes:
measure: Socio-Demographic and Medical Information Questionnaire
timeFrame: Baseline (week 0)
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa
state: Ontario
Study officials:
References:
citation: Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
citation: Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
citation: Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
citation: Husson O, Zebrack BJ. Psychometric Evaluation of an Adolescent and Young Adult Module of the Impact of Cancer Instrument. J Adolesc Young Adult Oncol. 2017 Mar;6(1):159-170. doi: 10.1089/jayao.2016.0038. Epub 2016 Sep 21.
citation: Marcus BH, Rakowski W, Rossi JS. Assessing motivational readiness and decision making for exercise. Health Psychol. 1992;11(4):257-61. doi: 10.1037//0278-6133.11.4.257.