Trial · NCT06828003
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Enrollment | Change from baseline (pre- intervention) to post-intervention (8 weeks). | Participant enrollment rate will be one measure of feasibility. Enrollment will be calculated by measuring the number of participants who enrolled in the intervention, divided by the number of participants who were assessed for eligibility |
| Primary | Adherence | Change from baseline (pre- intervention) to post-intervention (8 weeks). | Participant adherence will be one measure of feasibility. Adherence will be measured by assessing the number of exercise sessions attended divided by the total number of exercise sessions that take place (i.e., 16 sessions). Additionally, adherence to the exercise intensity will be reported by assessing the reported RPE and HR of participants during each session. |
| Primary | Attrition | Change from baseline (pre- intervention) to post-intervention (8 weeks). | Attrition will be one measure of feasibility. Attrition will be measured by calculating the number of participants who did not complete the intervention, divided by the number of participants who completed the entirety of the intervention. |
| Primary | Adverse Events | Change from baseline (pre- intervention) to post-intervention (8 weeks). | Adverse events will be one measure of feasibility. This will be assessed as an unexpected and severe medical problem or injury (e.g., cardiac-related events, musculoskeletal injury or pain, falls) that occurs as a result of the intervention. |
| Primary | Participant Satisfaction | Post-intervention (8 weeks). | A participant satisfaction survey will be administered following the 8-week intervention to assess the acceptability of the intervention by using researcher-generated statements (e.g., "I found the resistance training intervention rewarding"). The survey will assess the burden of the program and the participant's feedback regarding the RT program and overall study experience. Likert scales ranging from 1 (not at all) to 5 (very much) will be used. |
| Primary | Therapeutic Alliance | Post-intervention (8 weeks). | Therapeutic alliance will be measured using a modified version of the Working Alliance Inventory Short Revised (WAI-SR). Participants will respond to 12-items of statements and questions about experiences participants might have had with their instructor (e.g., \[INSTRUCTOR\] and I respect each other\]. Participants will rate their responses on a scale from 1 (seldom) to 5 (always). Higher scores indicate better therapeutic alliance. |
| Secondary | Objective Cognitive Function | Change from baseline (pre-intervention) to post-intervention (8 weeks). | Objective cognitive function will be assessed at baseline and follow-up using the National Institutes of Health (NIH) Toolbox Cognition Battery. The assessment will consist of 5 test instruments: the Picture Sequence Memory Test (episodic memory); the Picture Vocabulary Test (Language-Vocabulary Comprehension); the Oral Reading Recognition Test (Language-Reading Decoding); the List Sorting Working Memory Test (working memory); and the Auditory Verbal Learning Test (working memory). To supplement these tests, the PsyToolkit will be used to deliver the Stroop test (executive function). The cognitive assessments will be delivered remotely via a shared iPad screen and videoconferencing (i.e., Zoom). |
| Secondary | Subjective Cognitive Function | Change from baseline (pre- intervention) to post-intervention (8 weeks). | Subjective cognitive function will be assessed at baseline and follow-up using the Functional Assessment of Cancer Therapy-Cognitive Function Version 3 (FACT-Cog v3). This questionnaire will assess cognitive symptoms in the previous 7 days in four domains: perceived impairments, perceived abilities, quality of life, and comments from others. Participants will be asked to rate 37 items related to perceived cognitive complaints on a 5-point Likert scale (0= "not at all" or "never and 4= "very much" or "several times/day) where higher scores indicate fewer cognitive problems and better quality of life. |
| Secondary | Physical Function | Change from baseline (pre- intervention) to post-intervention (8 weeks). | Physical function will be measured at baseline and follow-up using the remotely-delivered 30-second sit-to-stand test. The purpose of the 30-second sit-to-stand test is to measure participants' lower body strength and endurance by measuring the number of full chair stands with arms folded at the chest completed in 30-seconds. A qualified exercise professional will oversee timing the participant and counting the number of full stands. Higher scores indicate better physical function. |
| Secondary | Self-Reported Exercise | Change from baseline (pre- intervention) to post-intervention (8 weeks). | Self-reported exercise will be measured using the modified Godin Leisure-Time Exercise Questionnaire (GLTEQ). Participants will report the number of times per week and duration that they engage in light, moderate, and vigorous leisure-time exercise, and resistance exercise. Total weekly minutes of MVPA will be calculated as the sum of the number of moderate exercise minutes per week, plus twice the number of vigorous exercise minutes per week. Total RT score will be calculated by summing the number of days spent in RT activities per week. |
| Secondary | Self-Reported Fatigue | Change from baseline (pre- intervention) to post-intervention (8 weeks). | Fatigue will be assessed at baseline and follow-up using the Functional Assessment of Chronic Illness Therapy- Fatigue Scale (FACIT-Fatigue). The FACIT-Fatigue is a 13-item measure will assess self-reported fatigue and its impact upon daily activities and function. Participants will be asked to rate 13 items related to their fatigue in the previous 7 days on a 5-point Likert scale (0="not at all" or "never" and 4= "very much" or "several times/day) where higher scores indicate higher quality of life. |
| Secondary | Anxiety and Depression | Baseline (pre- intervention) and post-intervention (8 weeks). | Anxiety and depression will be assessed at baseline and post-intervention as an exploratory variable using the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item instrument comprised of an anxiety subscale score (HADS-A), a depression subscale score (HADS-D) and a total score (HADS-T), where higher scores indicate higher distress. Each item on the HADS is rated on a 4-point Likert scale, where 0= "not at all" and 3= "yes, definitely". |
| Secondary | Clinical Demographics | Baseline (pre-intervention) | Clinical variables include: cancer type, date of diagnosis, cancer stage, cancer spread, cancer stage, treatment, current treatment status, recurrences, other cancer diagnoses, general health status, comorbidities, concussion history, smoking history, alcohol consumption history. |
| Secondary | Age | Baseline (pre-intervention) | Demographic variable of age will be assessed. Units of measurement is years. |
| Secondary | Sex | Baseline (pre-intervention) | Demographic variable of biological sex will be assessed. Response options are; male and female. |
| Secondary | Gender | Baseline (pre-intervention) | Demographic variable of gender will be assessed. Response options include; agender, bigender/multigender, gender fluid, genderqueer, man, nonbinary, transgender, two-spirit, woman, and other. |
| Secondary | Marital Status | Baseline (pre-intervention) | Demographic variable of marital status will be assessed. Response options are; single, married, common-law, separated, widowed, and divorced. |
| Secondary | Highest Level of Education | Baseline (pre-intervention) | Demographic variable of highest level of education will be assessed. Response options are; some high school, completed high school, some university/college, completed university/college, some graduate school, completed graduate school. |
| Secondary | Current Employment Status | Baseline (pre-intervention) | Demographic variable of current employment status will be assessed. Response options are; disability, retired, part-time, homemaker, full-time, and unemployed. |
| Secondary | Ethnicity | Baseline (pre-intervention) | Demographic variable of ethnicity will be assessed. Response options are; White, Chinese, South Asian, Black or African American, Latin American, South East Asian (Cambodian, Indonesian, Laotian, Vietnamese), Arab, West Asian (Afghan, Iranian), East Asian (Japanese, Taiwan), and other. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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