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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
75
Participate in online resistance training sessions
Given educational materials
Participate in online nutritional counseling
Ancillary studies
Ancillary studies
Ancillary studies
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
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
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
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
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
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
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
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
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
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
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
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
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
Anthropometry Height in Inches
At end-of-intervention, participants' height was assessed using height in centimeters.
Time frame: end-of-intervention, at 12 weeks
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
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