Physical Activity Counselling for Young Adult Cancer Survivors

Cancer Clinical Trial

Official title:

Physical Activity Counselling for Young Adult Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04163042
• Other study ID #: 20190643-01H
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: April 21, 2023

Study information

• Verified date: January 2024
• Source: University of Ottawa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 21, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Survivorship

Intervention

Behavioral:
• 12-week videoconferencing behavioural support intervention to promote physical activity behaviour
Participants in Group A will receive six real-time, 1-on-1 60-minute sessions led by a physical activity counsellor over a 12-week period. Sessions will be delivered via videoconferencing and will aim to provide young adult cancer survivors with support as well as the knowledge, skills, and confidence to identify and overcome challenges to engaging in physical activity in order to increase physical activity behaviour and enhance patient-reported outcomes.

Locations

Country	Name	City	State
Canada	University of Ottawa	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Ottawa

Country where clinical trial is conducted

Canada, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Socio-Demographic and Medical Information Questionnaire	Self-reported socio-demographic and medical information (e.g., age, gender, civil and educational status, ethnicity) will be collected and used to describe the sample. Participants will be provided with a range of response options for each item.	Baseline (week 0)
Primary	Recruitment rates	The number of eligible participants who enrol in the trial out of the number who are referred	Duration of study (24 months)
Primary	Adherence rates	The number of intervention sessions attended out of the total recommended as part of the intervention	Duration of study (24 months)
Primary	Acceptability of the trial and intervention	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').	At week 12
Primary	Retention rates	The number of participants completing all three scheduled assessments.	Duration of study (24 months)
Primary	Data completeness: Quantitative measures	The percentage of missing data on quantitative measures.	Duration of study (24 months)
Primary	Data completeness: Qualitative interviews	The number of participants completing the acceptability interview following the intervention.	Duration of study (24 months)
Secondary	Physical activity behaviour: 7-day accelerometer wear (objective physical activity behaviour)	Change in participants' objective levels of physical activity as measured by accelerometers (ActiGraph GT3X+), which will be worn for a 7-day period across baseline (week 0), post-intervention (week 12), and follow-up (week 24).	Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24)
Secondary	Health-related quality of life: RAND 36-Item Short Form Health Survey (SF-36; Ware & Sherbourne, 1992)	Change in participants' self-reported health-related quality of life across baseline (week 0), post-intervention (week 12) and post-intervention follow-up (week 24). The SF-36 measures eight dimensions: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Each item is scored on a 0 to 100 scale, with higher scores representing a more favourable health state.	Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24)
Secondary	Positive and negative affect: Positive and Negative Affect Schedule (PANAS-SF; Watson, Clark & Tellegen, 1998)	Change in participants' self-reported positive and negative affect across baseline (week 0), post-intervention (week 12) and post-intervention follow-up (week 24). Each item is scored on a scale from 1 ('Very slightly or not at all') to 5 ('Extremely'). Items in the positive scale are averaged together to create a Positive Affect Score, and items in the negative scale are averaged together to create a Negative Affect Score. Higher positive and negative scores represent higher positive and negative affect, respectively.	Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24)
Secondary	Depressive symptoms: Patient Health Questionnaire Depression Scale (PHQ-9; Kroenke, Spitzer & Williams, 2001)	Change in participants self-reported depressive symptoms across baseline (week 0), post-intervention (week 12) and post-intervention follow-up (week 24). Each item is scored on a 0 ('Not at all') to 3 ('Nearly every day') scale with higher scores representing greater severity of depressive symptoms.	Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24)
Secondary	Anxiety symptoms: 7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7; Kroenke, Spitzer & Williams, 2006)	Change in participants self-reported anxiety symptoms across baseline (week 0), post-intervention (week 12) and post-intervention follow-up (week 24). Each item is scored on a 0 ('Not at all') to 3 ('Nearly every day') scale, with higher scores representing greater severity of anxiety symptoms.	Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24)
Secondary	Impact of cancer: Impact of Cancer Instrument - Adolescent and Young Adult Module (Husson & Zebrack, 2017)	Change in participants' self-reported perceptions of cancer impact from baseline (week 0), post-intervention (week 12) and post-intervention follow-up (week 24). Each item is scored on a scale from 0 ('Strongly disagree') to 4 ('Strongly agree'), with higher scores representing greater impact of cancer.	Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24)
Secondary	Motivation for physical activity: Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3; Markland & Tobin, 2004)	Change in participants' self-reported motivation for physical activity across baseline (week 0), post-intervention (week 12) and post-intervention follow-up (week 24). This measure taps six behavioural regulations in the physical activity context: amotivation, external, introjected, identified, integrated, and intrinsic motivation. Each item is scored on a scale from 0 ('Not true for me') to 4 ('Very true for me'), with higher scores reflecting greater amotivation, external, introjected, identified, integrated, and intrinsic motivation for physical activity.	Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24)
Secondary	Basic psychological need satisfaction in relation to physical activity: Psychological Need Satisfaction in Exercise Scale (PNSE; Wilson, Rogers & Rodgers, 2006)	Change in participants self-reported psychological need satisfaction in relation to physical activity across baseline (week 0), post-intervention (week 12) and post-intervention follow-up (week 24). The PNSE measures perceptions of competence, autonomy and relatedness in relation to physical activity. Each item is scored on a scale from 1 ('False') to 6 ('True'), with higher scores representing greater perceived competence, autonomy and relatedness.	Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24)
Secondary	Autonomy support, structure and interpersonal involvement: Health Care Climate Questionnaire (Marcus et al., 1992)	Participants perceived sense of autonomy support, structure and interpersonal involvement for physical activity post-intervention (week 12). Each item is scored on a scale from 1 ('Strongly disagree') to 7 ('Strongly agree'), with higher scores representing greater perceived autonomy support, structure and interpersonal involvement for physical activity.	Post-intervention (week 12)

External Links

•   Behavioural Regulation in Exercise Questionnaire-3
•   Psychological Need Satisfaction in Exercise Scale