Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Stage I Colorectal Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage I Prostate Cancer AJCC v8
Conditions
Brief summary
This phase I trial tests the feasibility, acceptability, and preliminary effectiveness of online dietary and resistance training to improve physical function in older (greater than or equal to 65-years old) cancer survivors. Declines in adequate protein and calorie intake results in faster loss of muscle mass and physical functioning in older adults. A novel approach to improving physical function in older cancer survivors (OCS) is to utilize online, tailored education and counseling from registered dietitians and exercise scientists, to improve dietary intake (protein intake, diet quality) and participation in resistance exercise. The purpose of this study is to help researchers learn whether an online dietary and resistance training intervention improves diet, exercise, physical function, and health outcomes in OCS.
Detailed description
PRIMARY OBJECTIVES: I. Determine the feasibility and acceptability of implementing a 12-week online dietary and resistance training randomized trial with 70 older cancer survivors. II. Examine the preliminary efficacy of this 12-week online dietary and resistance training intervention with the intervention participants. OUTLINE: Patients are randomized to 1 of 2 arms. ARM 1: Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline. ARM 2: Patients receive educational materials at baseline. After completion of study intervention, patients are followed up at 3 months.
Interventions
OTHERExercise Intervention
Participate in online resistance training sessions
OTHERInformational Intervention
Given educational materials
OTHERNutritional Assessment
Participate in online nutritional counseling
OTHERPhysical Performance Testing
Ancillary studies
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
National Institute on Aging (NIA)
Ohio State University Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>= 65 years of age * A primary diagnosis of stage I-III breast, colorectal, and prostate cancer * Completion of primary curative treatment * Reported at least 1 physical function limitation on the RAND-36 Physical Function Subscale (PFSS) (limited a little, limited a lot) * No evidence of progressive disease or second cancers * Community-dwelling * Able to provide consent
Exclusion criteria
* Currently receive cancer treatment (e.g., chemotherapy, radiation) * Have liver and/or renal disease limiting their protein intake * Are under the care of a Registered Dietician (RD)/nutritionist * Participating in other diet/exercise interventions * Consume protein supplements * Have contraindications to unsupervised exercise (e.g., walker/wheelchair use)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Function at End-of-intervention | end-of-intervention, at 12 weeks | Measured by the Short Physical Performance Battery (SPPB) score. The SPPB score is a continuous variable, collected as the total score ranging from 0-12, higher scores denote higher physical function. Values reported are at the end-of-intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Study Accrual Rate | assessed during the 12 month recruitment period | Will be calculated by dividing the number of potential participants that passed screening by the total number of participants started in the study after appropriate informed consent procedures. |
| Study Retention Rate | End-of-study, up to 3 months | calculated by dividing the total number of participants initiated by total number of participants in the study. Retention goal for this trial is 80%. If 80% (56/70) of participants are retained at end-of-study, the retention goal for this trial will be achieved. Overall retention rates and associated 95% confidence intervals will be reported. |
| Study Adherence Rate | end-of-intervention, at 12 weeks | Participants were determined to be adherent if they attend \>= 80% of the online intervention sessions. Overall adherence rates and associated 95% confidence intervals were reported. |
| Grip Strength | end-of-intervention, at 12 weeks | Handgrip strength (absolute value at the end of the intervention) was measured in both hands using a hydraulic grip strength dynamometer. This is measured in kgs. |
| Dietary Quality | end-of-intervention, at 12 weeks | Dietary quality was assessed by the National Cancer Institute's Diet History Questionnaire III using the Healthy Eating Index score ranging 0-100, with higher scores meaning higher diet quality. Absolute value at end-of-intervention was assessed using the Healthy Eating Index score. |
| Percentage of Participants Who Completed Resistance Exercises | end-of-intervention, at 12 weeks | Self-reported resistance exercise (% yes) was assessed using the revised version of The Godin-Shephard Leisure-Time Exercise Questionnaire modified to specifically capture self-reported resistance exercise participation. If a participant denoted yes to the question: did During a typical 7-Day period (a week), did you participate in resistance exercise for more than 15 minutes during your free time? Percentages denote the percentage of the study subjects who participated in resistance training at end of intervention. |
| Satisfaction of the Delivery Method and Information Provided by Nutrition and Exercise Counseling Sessions | end-of-intervention, at 12 weeks | Percentage of participant satisfaction (satisfied and very satisfied) measured by a 5-item Likert-scale questionnaire. Scores range from 1-5, with 5 being the highest score of satisfaction. |
| Self-efficacy | end-of-intervention, at 12 weeks | Self-efficacy was measured at the end of intervention via a 0-10 confidence scale rating the confidence of making exercise and diet changes in one's life, with 0 meaning not confident, 10 meaning very confident. |
| Technology Competency | end-of-intervention, at 12 weeks | The 8-item eHealth Literacy Scale measured knowledge, comfort, and perceived skills of engaging in eHealth at end-of-intervention. A 5-point Likert scale was used, with possible scores ranging from 8 to 40. Higher scores indicate higher ehealth literacy. |
| Anthropometry Body Weight in Kilograms | end-of-intervention, at 12 weeks | At end-of-intervention, participant's body weight was assessed in kilograms. |
| Anthropometry Height in Inches | end-of-intervention, at 12 weeks | At end-of-intervention, participants' height was assessed using height in centimeters. |
| Anthropometry Measuring Waist Circumference in Centimeters | end-of-intervention, at 12 weeks | At end-of-intervention, participants' waist circumference was assessed in centimeters. |
| Health-related Quality of Life (HRQoL) | end-of-intervention, at 12 weeks | RAND-36 Health Status Measure is comprised of 36 items which automatically create 8 subscales assessing multiple aspects of HRQoL. All scores range from 0-100, with 100 as the highest HRQoL. The main HRQoL subscale reported is the general health HRQoL subscale. Mean scores of general HRQoL for end-of-intervention are reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 (Nutritional Counseling, Resistance Training) Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline.
Exercise Intervention: Participate in online resistance training sessions
Informational Intervention: Given educational materials
Nutritional Assessment: Participate in online nutritional counseling
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies | 38 |
| Arm 2 (Educational Materials) Patients receive educational materials at baseline.
Informational Intervention: Given educational materials
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies | 37 |
| Total | 75 |
Baseline characteristics
| Characteristic | Arm 1 (Nutritional Counseling, Resistance Training) | Arm 2 (Educational Materials) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 38 Participants | 37 Participants | 75 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 69 years | 70 years | 70 years |
| Diet History Questionnaire III | 66.9 units on a scale | 65.8 units on a scale | 66.3 units on a scale |
| eHealth Literacy Scale | 33.4 units on a scale STANDARD_DEVIATION 5.4 | 32.3 units on a scale STANDARD_DEVIATION 6.9 | 32.8 units on a scale STANDARD_DEVIATION 6.2 |
| Godin leisure time exercise | 43 units on a scale STANDARD_DEVIATION 9.8 | 42 units on a scale STANDARD_DEVIATION 9.2 | 43 units on a scale STANDARD_DEVIATION 9.6 |
| Grip strength | 27.3 kg STANDARD_DEVIATION 4.8 | 26.8 kg STANDARD_DEVIATION 4.3 | 27.0 kg STANDARD_DEVIATION 4.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 30 Participants | 33 Participants | 63 Participants |
| RAND-36 | 64.2 units on a scale STANDARD_DEVIATION 19.2 | 63.0 units on a scale STANDARD_DEVIATION 21.3 | 63.6 units on a scale STANDARD_DEVIATION 20.1 |
| Region of Enrollment United States | 38 participants | 37 participants | 75 participants |
| Self-efficacy for diet and exercise | 7.6 units on a scale STANDARD_DEVIATION 2.1 | 8.6 units on a scale STANDARD_DEVIATION 2.3 | 8.08 units on a scale STANDARD_DEVIATION 2.2 |
| Self-regulation for diet and exercise | 35.7 units on a scale STANDARD_DEVIATION 9.8 | 35.6 units on a scale STANDARD_DEVIATION 10.3 | 35.7 units on a scale STANDARD_DEVIATION 9.9 |
| Sex: Female, Male Female | 26 Participants | 26 Participants | 52 Participants |
| Sex: Female, Male Male | 12 Participants | 11 Participants | 23 Participants |
| Short Physical Performance Battery | 9.2 units on a scale | 9.1 units on a scale | 9.1 units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 37 |
| other Total, other adverse events | 0 / 38 | 0 / 37 |
| serious Total, serious adverse events | 0 / 38 | 0 / 37 |
Outcome results
Primary
Physical Function at End-of-intervention
Measured by the Short Physical Performance Battery (SPPB) score. The SPPB score is a continuous variable, collected as the total score ranging from 0-12, higher scores denote higher physical function. Values reported are at the end-of-intervention.
Time frame: end-of-intervention, at 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 (nutritional counseling, resistance training) | Physical Function at End-of-intervention | 9.2 score on a scale | Standard Deviation 2.2 |
| Arm 2 (educational materials) | Physical Function at End-of-intervention | 9.1 score on a scale | Standard Deviation 2.3 |
Secondary
Anthropometry Body Weight in Kilograms
At end-of-intervention, participant's body weight was assessed in kilograms.
Time frame: end-of-intervention, at 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm 1 (nutritional counseling, resistance training) | Anthropometry Body Weight in Kilograms | 28 kg |
| Arm 2 (educational materials) | Anthropometry Body Weight in Kilograms | 29 kg |
Secondary
Anthropometry Height in Inches
At end-of-intervention, participants' height was assessed using height in centimeters.
Time frame: end-of-intervention, at 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 (nutritional counseling, resistance training) | Anthropometry Height in Inches | 165.2 cm | Standard Deviation 5.2 |
| Arm 2 (educational materials) | Anthropometry Height in Inches | 166.1 cm | Standard Deviation 4.8 |
Secondary
Anthropometry Measuring Waist Circumference in Centimeters
At end-of-intervention, participants' waist circumference was assessed in centimeters.
Time frame: end-of-intervention, at 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm 1 (nutritional counseling, resistance training) | Anthropometry Measuring Waist Circumference in Centimeters | 100 cm |
| Arm 2 (educational materials) | Anthropometry Measuring Waist Circumference in Centimeters | 101 cm |
Secondary
Dietary Quality
Dietary quality was assessed by the National Cancer Institute's Diet History Questionnaire III using the Healthy Eating Index score ranging 0-100, with higher scores meaning higher diet quality. Absolute value at end-of-intervention was assessed using the Healthy Eating Index score.
Time frame: end-of-intervention, at 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1 (nutritional counseling, resistance training) | Dietary Quality | 69.3 score on a scale |
| Arm 2 (educational materials) | Dietary Quality | 68.1 score on a scale |
Secondary
Grip Strength
Handgrip strength (absolute value at the end of the intervention) was measured in both hands using a hydraulic grip strength dynamometer. This is measured in kgs.
Time frame: end-of-intervention, at 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 (nutritional counseling, resistance training) | Grip Strength | 28.6 kgs | Standard Deviation 5.2 |
| Arm 2 (educational materials) | Grip Strength | 28.3 kgs | Standard Deviation 4.8 |
Secondary
Health-related Quality of Life (HRQoL)
RAND-36 Health Status Measure is comprised of 36 items which automatically create 8 subscales assessing multiple aspects of HRQoL. All scores range from 0-100, with 100 as the highest HRQoL. The main HRQoL subscale reported is the general health HRQoL subscale. Mean scores of general HRQoL for end-of-intervention are reported.
Time frame: end-of-intervention, at 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 (nutritional counseling, resistance training) | Health-related Quality of Life (HRQoL) | 53.8 score on a scale | Standard Error 18.9 |
| Arm 2 (educational materials) | Health-related Quality of Life (HRQoL) | 60.1 score on a scale | Standard Error 19.1 |
Secondary
Percentage of Participants Who Completed Resistance Exercises
Self-reported resistance exercise (% yes) was assessed using the revised version of The Godin-Shephard Leisure-Time Exercise Questionnaire modified to specifically capture self-reported resistance exercise participation. If a participant denoted yes to the question: did During a typical 7-Day period (a week), did you participate in resistance exercise for more than 15 minutes during your free time? Percentages denote the percentage of the study subjects who participated in resistance training at end of intervention.
Time frame: end-of-intervention, at 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 (nutritional counseling, resistance training) | Percentage of Participants Who Completed Resistance Exercises | 97 percentage of participants |
| Arm 2 (educational materials) | Percentage of Participants Who Completed Resistance Exercises | 65 percentage of participants |
Secondary
Satisfaction of the Delivery Method and Information Provided by Nutrition and Exercise Counseling Sessions
Percentage of participant satisfaction (satisfied and very satisfied) measured by a 5-item Likert-scale questionnaire. Scores range from 1-5, with 5 being the highest score of satisfaction.
Time frame: end-of-intervention, at 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1 (nutritional counseling, resistance training) | Satisfaction of the Delivery Method and Information Provided by Nutrition and Exercise Counseling Sessions | 5 score on a scale |
| Arm 2 (educational materials) | Satisfaction of the Delivery Method and Information Provided by Nutrition and Exercise Counseling Sessions | 5 score on a scale |
Secondary
Self-efficacy
Self-efficacy was measured at the end of intervention via a 0-10 confidence scale rating the confidence of making exercise and diet changes in one's life, with 0 meaning not confident, 10 meaning very confident.
Time frame: end-of-intervention, at 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 (nutritional counseling, resistance training) | Self-efficacy | 9.47 score on a scale | Standard Deviation 2.1 |
| Arm 2 (educational materials) | Self-efficacy | 8.97 score on a scale | Standard Deviation 1.9 |
Secondary
Study Accrual Rate
Will be calculated by dividing the number of potential participants that passed screening by the total number of participants started in the study after appropriate informed consent procedures.
Time frame: assessed during the 12 month recruitment period
Population: The number of participants analyzed represents all potential older cancer survivors (OCS) contacted and assessed for eligibility for participation in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 (nutritional counseling, resistance training) | Study Accrual Rate | 23.1 percentage of participants |
Secondary
Study Adherence Rate
Participants were determined to be adherent if they attend \>= 80% of the online intervention sessions. Overall adherence rates and associated 95% confidence intervals were reported.
Time frame: end-of-intervention, at 12 weeks
Population: Percentage of Participants who Attended \>= 80% of the Intervention Sessions
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 (nutritional counseling, resistance training) | Study Adherence Rate | 97 percentage of participants |
| Arm 2 (educational materials) | Study Adherence Rate | 95 percentage of participants |
Secondary
Study Retention Rate
calculated by dividing the total number of participants initiated by total number of participants in the study. Retention goal for this trial is 80%. If 80% (56/70) of participants are retained at end-of-study, the retention goal for this trial will be achieved. Overall retention rates and associated 95% confidence intervals will be reported.
Time frame: End-of-study, up to 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1 (nutritional counseling, resistance training) | Study Retention Rate | 30 Participants |
| Arm 2 (educational materials) | Study Retention Rate | 33 Participants |
Secondary
Technology Competency
The 8-item eHealth Literacy Scale measured knowledge, comfort, and perceived skills of engaging in eHealth at end-of-intervention. A 5-point Likert scale was used, with possible scores ranging from 8 to 40. Higher scores indicate higher ehealth literacy.
Time frame: end-of-intervention, at 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1 (nutritional counseling, resistance training) | Technology Competency | 33.9 score on a scale |
| Arm 2 (educational materials) | Technology Competency | 33.2 score on a scale |