Cancer, Functional Limitation, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Conditions
Keywords
Cancer, Exercise, Cancer survivor, Functional limitation, Clinical trial, Older adult, Feasibility
Brief summary
The study will assess the feasibility and preliminary efficacy of live, online supervised group functional resistance training in older cancer survivors who may have difficulty with independent functioning. The study design is a three-arm parallel group randomized controlled trial (immediate resistance training, delayed resistance training, stretching placebo) in 150 older cancer survivors. The resistance training program will be compared to two different types of common control groups: a stretching placebo group and a delayed intervention group. By using two control conditions, this study can also inform the design of future randomized trials on the selection of an appropriate control group.
Detailed description
This study is designed to begin addressing the current gap in evidence-based exercise guidelines for older cancer survivors, many of whom are at risk for losing their functional independence. This study is a three-arm parallel group randomized feasibility trial of 16 weeks of live, online supervised group functional resistance training in older (age 65+) cancer survivors (stages I - IV, including hematological malignancies) with or at risk for a functional limitation (n=150). Participants will be randomized in a 1:1:1 ratio to one of three study arms (immediate progressive functional resistance training (PFRT) intervention, stretching placebo; or, delayed PFRT), stratified by disease stage (metastatic vs non-metastatic). For both the immediate PFRT arm and the stretching placebo, participants will attend three 45-minute live, online supervised group sessions per week for 16 weeks. The immediate PFRT arm progresses from low to moderate intensity over 16 weeks based on participant tolerance. The stretching arm will perform stretches seated in a chair and will emphasize whole body range of motion and relaxation. The delayed PFRT arm will receive educational information about healthy lifestyle behaviors and monthly check-in calls over the first 16 weeks, then will follow the same exercise protocol as the immediate PFRT arm for an additional 16 weeks, during which feasibility outcomes will be collected. All participants will undergo two assessments (baseline and post-intervention at 16 weeks), consisting of surveys and performance assessments. The primary objective is to evaluate acceptability, tolerability, and safety of live, online supervised group functional resistance training sessions, as assessed by loss-to-follow-up, permanent discontinuation (i.e., study withdrawal), attendance to exercise sessions, treatment interruption, exercise dose modification, pre-treatment dose modification, tolerability (i.e., relative dose intensity), and prevalence and attribution status of adverse events. The secondary objective is to assess preliminary effects of the intervention on physical and mental health outcomes, including objectively measured physical function (Timed Up and Go, Physical Performance Battery), patient-reported symptoms and health related quality of life (Patient Reported Outcomes Measurement Information System (PROMIS) FACIT-Fatigue, Sleep Disturbance, Depression, Physical Function, Pain Intensity, Cognition, Anxiety; EuroQoL-5 Dimensions, European Organisation for Research and Treatment of Cancer QoL Questionnaire-Core 30), functional independence and disability (Nottingham Extended Activities of Daily Living, Late-Life Function and Disability Instrument), life-space mobility (Life Space Assessment), cognitive screening (Montreal Cognitive Assessment), frailty indicators (Chair Stand Test, 4-Meter Walk Test, self-reported physical activity and fatigue, and unintentional weight loss), and physical activity behaviors (Community Healthy Activities Model Program for Seniors).
Interventions
Participants attend live, online supervised group functional resistance training sessions of low-to-moderate intensity exercises, three times per week, 45 minutes per session for 16 weeks.
OTHERStretching
Participants attend live, online supervised group stretching and relaxation training sessions three times per week, 45 minutes per session for 16 weeks.
OTHERDelayed Functional Resistance Training
Participants will receive educational information about healthy lifestyle behaviors and receive monthly check in calls from study staff. After 16 weeks, participants attend live, online supervised group functional resistance training sessions of low-to-moderate intensity exercises, three times per week, 45 minutes per session for 16 weeks.
Sponsors
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
All adverse events will be reviewed on a quarterly basis by the research team in a blinded fashion with respect to study arm and categorized based on severity as serious, moderate, or mild, and attribution to the intervention as attributable, possibly attributable, or non-attributable.
Intervention model description
Three-arm, parallel group, randomized clinical trial.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 65 years of age or older * Diagnosed with stage I-IV cancer =\< 5 years ago * Completed surgery, chemotherapy, or radiation therapy \> 3 months ago (concurrent maintenance therapy, such as hormone therapy for breast or prostate cancer, is permissible) * Self-report at least one limitation in Activities of Daily Living (ADLs) OR at clinical risk of developing ADL impairment as evidenced by a 3-meter timed-up-and-go time \> 13.5 seconds or 5-time chair stand time \> 12 seconds * Able to ambulate independently; reliance on assistive devices other than a wheelchair is allowed * Currently underactive (an average of \< 30 minutes of moderate-vigorous intensity exercise 3 days/week over the past four weeks) * Willing to be randomized into any of the three study arms and attend 80% or more of planned exercise sessions * Home internet sufficient for videoconferencing
Exclusion criteria
* Contraindication to moderate intensity exercise * Health or medical condition that affects movement or neurological disorder, or medication that contraindicates participation in live remote resistance exercise * Cognitive impairment consistent with moderate dementia (confirmed by a Montreal Cognitive Assessment (MoCA) score \< 14). Cognitive impairment consistent with early-stage dementia (a MoCA score of \<20) unless a research partner (e.g., family member, caregiver, close friend) can also be consented and can assist in answering the survey questions, participating in the performance tests, or giving informed consent. * Not fluent in English and therefore incapable of answering survey questions, following directions during exercise or performance testing, and providing informed consent in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Loss-to-Follow Up | 16 weeks | Measured by the percentage of enrolled participants not completing baseline and 16-week survey or performance testing. |
| Permanent Discontinuation | 16 weeks | Measured by the percentage of enrolled sample that the participant and/or the investigator withdraws before final study visit. |
| Attendance | 16 weeks | Measured by the percentage of prescribed online sessions attended over the intervention period |
| Treatment Interruption | 16 weeks | Measured by number of times 3+ consecutive sessions are missed over the 16 week intervention period |
| Dose Modification | 16 weeks | Measured by the number of sessions requiring reduction or escalation in intensity and/or duration (sets or repetitions) after the session begins over the intervention period |
| Pre-treatment Dose Modification | 16 weeks | Measured by the number of times a session dose (intensity and/or duration) is reduced or escalated prior to the beginning of a session over the intervention period |
| Tolerability (Relative Dose Intensity) | 16 weeks | Measured by the cumulative dose of training received divided by the cumulative dose of prescribed training, expressed as a percentage over the intervention period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timed Up and Go (TUG) test | Baseline, 16 weeks | Physical assessment of mobility by evaluating the time that it takes a person to rise from a chair, walk 3 meters, turn around, and return and sit in the chair. Faster times indicate better mobility |
| Physical Performance Battery (PPB) test | Baseline, 16 weeks | Physical assessment of three timed tests (five repeated chair stands, standing balance, and usual pace gait speed over 4 meters), scored on a scale of 0 (unable) to 4 (completes without difficulty), based on quartiles of performance, then scores are summed, where higher scores indicate better physical functioning. |
| Patient Reported Outcomes Measurement Information System (PROMIS) FACIT-Fatigue Short Form 13a | Baseline, 16 weeks | Self-report on 13 questions about fatigue in the past seven days, on a scale ranging from 1 (not at all) to 5 (very much), where higher total scores indicate more fatigue. |
| PROMIS Sleep Disturbance Short Form 8a | Baseline, 16 weeks | Self-report on 8 questions about symptoms of sleep disturbance in the past seven days, on a scale ranging from 1 (not at all) to 5 (very much), where higher total scores indicate greater sleep disturbance. |
| PROMIS Depression Short Form 4a | Baseline, 16 weeks | Self-report on 4 questions on depressive symptoms in the past seven days, on a scale ranging from 1 (never) to 5 (always), where higher total scores indicate greater depressive symptoms. |
| PROMIS Physical Function Short Form 10a | Baseline, 16 weeks | Self-report on 10 questions of physical capability and instrumental activities of daily living, on a scale from 1 (unable to do) to 5 (without any difficulty), where higher scores indicate greater physical function. |
| PROMIS Pain Intensity Short Form 10a | Baseline, 16 weeks | Self-report on 3 questions about pain intensity over the past seven days, and current pain intensity, on a scale from 1 (had no pain) to 5 (very severe), where higher scores indicate greater pain intensity. |
| PROMIS Cognition Short Form 8a | Baseline, 16 weeks | Self-report on 8 questions about perceived cognitive function (i.e., memory, concentration, verbal fluency, and mental acuity) over the past seven days, on a scale from 1 (very often \[several times a day\]) to 5 (never), where higher scores indicate better cognitive function. |
| PROMIS Anxiety Short Form 4a | Baseline, 16 weeks | Self-report on 4 questions about fear, anxious misery, hyperarousal, and somatic symptoms related to arousal, on a scale from 1 (never) to 5 (always), where higher scores indicate worse anxiety-related symptoms. |
| EuroQoL-5 Dimensions (EQ-5D) Questionnaire | Baseline, 16 weeks | Self-report on health-related quality of life, with two components. 1) Five dimensions related to health (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is assigned a level from 1 (no problems) to 5 (extreme problems) and organized into a five-digit number representing the respondent's health state (e.g., 11235). Each 5-digit number corresponds to a health profile. 2) A visual analogue scale from 0 (worst imaginable health) to 100 (best imaginable health), where higher scores indicate better self-perceived health status. |
| European Organisation for Research and Treatment of Cancer QoL Questionnaire-Core 30 (QLQC-30) | Baseline, 16 weeks | Self-report on 30 questions about cancer-specific quality of life for five functional scales (physical, cognitive, emotional, social functioning, and role functioning) and one global health scale, on either a 4- (1=not at all to 4=very much) or 7-point (1=very poor to 7=excellent) Likert scale, where higher function-oriented scores indicate better functioning, and higher symptom-oriented scores indicate worse symptom severity. Transformed scores range from 0-100, where higher scores indicate better functioning. |
| Nottingham Scale for Extended Activities of Daily Living (NEADL) | Baseline, 16 weeks | Self-report on 22 questions about independence in instrumental activities of daily living (IADL; i.e., functional status) over four domains of activity (mobility, leisure, kitchen, and domestic tasks), on a scale from 0 (not at all) to 3 (on my own), where higher scores indicate more independence. |
| Life Space Questionnaire (LSQ) | Baseline, 16 weeks | Self-report on nine questions about movement across different spatial zones (i.e., community mobility) over the preceding three days, scored from 1 (yes) to 0 (no), where higher scores indicate greater mobility. |
| Late Life Function and Disability instrument (LLFDI) | Baseline, 16 weeks | Self-report on 16 questions about physical function and disability in two domains (frequency and limitation). The frequency scale is from 1 (never) to 5 (very often), where higher scores indicate more frequent participation in social and life activities. The limitation scale is from 1 (completely) to 5 (not at all), where higher scores indicate less limitations in completing activities. |
| Montreal Cognitive Assessment (MoCA) | Baseline, 16 weeks | Researcher-administered test of 11 questions used to screen for cognitive impairment, on a scale of 0-30 points, where higher scores (26+) indicate normal cognition, and lower scores indicate mild (18-15), moderate (10-17), or severe (\<10) cognitive impairment. |
| Adverse Event Prevalence and Attribution [Safety] | Monthly over the 16-week intervention period. | Self-report on adverse events (AE) experienced throughout study involvement, as reported on a monthly AE survey; prevalence, severity, and attribution to the intervention will be determined. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKerri Winters-Stone, Ph.D.
OHSU Knight Cancer Institute
Outcome results
None listed