Physical Activity Counselling for Young Adult Cancer Survivors

Sponsor
University of Ottawa (Other)
Overall Status
Recruiting
CT.gov ID
NCT04163042
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
25.7
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: 12-week videoconferencing behavioural support intervention to promote physical activity behaviour
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Physical Activity Counselling for Young Adult Cancer Survivors
Actual Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Apr 21, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Group A: Videoconferencing intervention

Participants allocated to group A will receive a behavioural support intervention via real-time videoconferencing.

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.

No Intervention: Group B: Usual care

Participants allocated to group B will receive usual care and will be advised to continue with their regular activities of daily living.

Outcome Measures

Primary Outcome Measures

  1. Recruitment rates [Duration of study (24 months)]

    The number of eligible participants who enrol in the trial out of the number who are referred

  2. Adherence rates [Duration of study (24 months)]

    The number of intervention sessions attended out of the total recommended as part of the intervention

  3. Acceptability of the trial and intervention [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').

  4. Retention rates [Duration of study (24 months)]

    The number of participants completing all three scheduled assessments.

  5. Data completeness: Quantitative measures [Duration of study (24 months)]

    The percentage of missing data on quantitative measures.

  6. Data completeness: Qualitative interviews [Duration of study (24 months)]

    The number of participants completing the acceptability interview following the intervention.

Secondary Outcome Measures

  1. Physical activity behaviour: 7-day accelerometer wear (objective physical activity behaviour) [Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24)]

    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).

  2. 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)]

    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.

  3. 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)]

    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.

  4. 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)]

    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.

  5. 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)]

    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.

  6. 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)]

    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.

  7. 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)]

    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.

  8. 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)]

    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.

  9. Autonomy support, structure and interpersonal involvement: Health Care Climate Questionnaire (Marcus et al., 1992) [Post-intervention (week 12)]

    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.

Other Outcome Measures

  1. Socio-Demographic and Medical Information Questionnaire [Baseline (week 0)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 39 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1University of OttawaOttawaOntarioCanadaK1N6N5

Sponsors and Collaborators

  • University of Ottawa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Jennifer Brunet, Associate professor, University of Ottawa
ClinicalTrials.gov Identifier:
NCT04163042
Other Study ID Numbers:
  • 20190643-01H
First Posted:
Nov 14, 2019
Last Update Posted:
Oct 14, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jennifer Brunet, Associate professor, University of Ottawa

Study Results

No Results Posted as of Oct 14, 2021