Physical Activity Counselling for Young Adult Cancer Survivors
NCT ID: NCT04163042
Last Updated: 2024-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2021-03-01
2023-04-21
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A: Videoconferencing intervention
Participants allocated to group A will receive a behavioural support intervention via real-time videoconferencing.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
39 Years
ALL
No
Sponsors
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University of Ottawa
OTHER
Responsible Party
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Jennifer Brunet
Associate professor
Locations
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University of Ottawa
Ottawa, Ontario, Canada
Countries
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References
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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.
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.
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.
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.
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.
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.
Brunet J, Price J, Srikanthan A, Gillison F, Standage M, Taljaard M, Beauchamp MR, Reed J, Wurz A. The physicAl aCtivity Counselling for young adult cancEr SurvivorS (ACCESS) trial: A protocol for a parallel, two-arm pilot randomized controlled trial. PLoS One. 2022 Dec 30;17(12):e0273045. doi: 10.1371/journal.pone.0273045. eCollection 2022.
Related Links
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Psychological Need Satisfaction in Exercise Scale
Behavioural Regulation in Exercise Questionnaire-3
Other Identifiers
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20190643-01H
Identifier Type: -
Identifier Source: org_study_id
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