Sarcoma
Conditions
Brief summary
This trial studies how well progressive resistance training works in improving the physical function of sarcoma survivors. Treatments for sarcoma can cause side effects such as fatigue, muscle loss, and weakness, which can negatively impact a patient's ability to physically function and enjoy an independent lifestyle. Engaging in a resistance training exercise routine may improve physical function, body composition, and bone density of sarcoma survivors.
Detailed description
PRIMARY OBJECTIVE: I. To determine the feasibility of a home-based individualized progressive resistance training (PRT) program in sarcoma survivors. SECONDARY OBJECTIVES: I. To assess secondary measures of feasibility of a home-based, individualized PRT program in sarcoma survivors. II. To determine if a 3-month PRT program improves physical function in sarcoma survivors. EXPLORATORY OBJECTIVE: I. To determine if a 3 month resistance training program improves body composition and bone mineral density. OUTLINE: Patients complete a series of progressive resistance training exercises at home twice weekly over 1 hour and receive instructional guidance from an exercise physiologist via videoconferencing once per week during one of these sessions for up to 12 weeks. After completion of study, patients are followed up at 3 months.
Interventions
OTHERExercise Counseling
Receive instructional guidance
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
OTHERResistance Training
Complete progressive resistance training
Sponsors
National Cancer Institute (NCI)
Oregon Health and Science University
OHSU Knight Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eligible for the Sarcoma Survivorship Registry (Institutional Review Board \[IRB\] #12039) * History of histologically-confirmed sarcoma * History of treatment with surgery, radiation and/or chemotherapy for the sarcoma diagnosis * Completion of sarcoma treatment \>= 2 years prior to study enrollment * No evidence of recurrent or residual disease on surveillance exam or imaging for at least 2 years prior to study enrollment * Sarcoma location must have been in the extremities, body wall, pelvic/shoulder girdle or axial skeleton. Intra-thoracic, intra-abdominal or cranial sarcomas are not eligible * Currently engaging in \< 1 hour of resistance exercise per week by self-report. Examples of resistance exercise include: using free weights or weight machines, push-ups, sit-ups, lunges, plank, etc. * Able and willing to commit to attending weekly video coaching sessions and independently completing weekly resistance training sessions. This requires access to internet and a device with video and audio capabilities. A webcam may be provided by the study to the participant if needed * Able and willing to commit to attending one initial in-person training session and one in-person follow-up assessment * Ability to understand and willingness to sign a written informed consent document
Exclusion criteria
* Medical contraindication(s) to any and all resistance training as determined by treating physician * Non-English speaking. At this time, we do not have resources to support translation of exercise physiologist (EP) sessions * Dependent on a mobility device (e.g., crutches, wheelchair) for independent activities of daily living (IADLs) * Use of a cane is permitted * Participant has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial * Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of participant safety or study results (e.g., pregnancy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention | From the time of enrollment up to 3 months end-of-intervention assessments | Number of evaluable participants who completed end-of-intervention assessments |
| Exercise Adherence | From the time of enrollment up to completion of 12 week exercise intervention | Number of participants who completed end-of-intervention assessments and completed at least 18 of 24 prescribed training sessions. |
| Frequency of Related Serious Adverse Events (SAEs) | From the time of enrollment up to completion of 12 week exercise intervention | Number of participants that experienced exercise-related SAEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Individualized Progressive Resistance Training (PRT) Prescriptions | From the time of enrollment up to completion of 12 week exercise intervention | Number of participants who received an individualized PRT prescription developed for the participant by the study exercise physiologist. |
| Mean Patient-Reported Outcomes Measurement Information System (PROMIS) - Cancer Physical Function Score Value | Baseline up to completion of 12 week exercise intervention | The PROMIS-Cancer assessment consists of 45 questions pertaining to physical function, each of which are designed as having five-point ordinal rating scales. Participants are asked to respond to questions regarding the extent of their physical function. Responses range from 1 to 5, where 1 represents unable to do and 5 represents without any difficulty. Each PROMIS assessment generates a T-score, which is a standardized score with a mean of 50 and standard deviation of 10 in a reference population of cancer patients, i.e., a score of 40 is one SD lower than the mean of the reference population. A PROMIS-Cancer Physical Function score less than 50 indicates patient-reported physical function worse than the cancer patient mean. The PROMIS T-scores are summarized with mean and standard deviation, with comparison of scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. |
| Change in Short Form-36 Physical Function Score | Baseline up to completion of 12 week exercise intervention | The 36-Item Short Form Health Survey (SF-36) consists of a set of generic, quality-of-life measures to survey physical function in the general population. Responses range from 0 - 100, with a higher score indicating a more favorable health state. Will be summarized as mean and standard deviation. Will also compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. |
| Change in Godin Leisure-Time Exercise Questionnaire Physical Activity Score (GLTEQ) | Baseline up to completion of 12 week exercise intervention | To score the GLTEQ, the weekly frequencies of strenuous, moderate, and light activities are multiplied by nine, five, and three, respectively. Total weekly leisure activity is calculated in arbitrary units by summing the products of the separate components as shown in the following formula: Weekly leisure activity score = (9xStrenuous) + (5x Moderate) + (3xLight). Responses range from 0 - greater than 24, with 0 indicating no activity and a higher score indicating more activities (no maximum score). GLTEQ will be summarized as mean and standard deviation. Will also compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. |
| Change in Functional Assessment of Chronic Illness Therapy-Fatigue Score (FACT-F) | Baseline up to completion of 12 week exercise intervention | Fatigue was assessed using the FACT-F scale. This is a 13 item, uni-dimensional, 5-point Likert scale, measuring physical fatigue over the past week. The scale has high internal consistency and is widely used in the literature. Responses range from 0 - 52, with a higher score indicating more fatigue. FACT-F will be summarized as mean and standard deviation. Will also compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. |
| Difference in 1-repetition Maximum (Kilogram) | Baseline up to completion of 12 week exercise intervention | Compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. Will initially examine distribution of each outcome variable using Shapiro-Wilk test, as well as data visualization techniques as standard practice. Will consider transforming the data or adopting non-parametric approaches if normality assumption is violated. |
| Change in Short Physical Performance Battery Score | Baseline up to completion of 12 week exercise intervention | Compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. Will initially examine distribution of each outcome variable using Shapiro-Wilk test, as well as data visualization techniques as standard practice. Will consider transforming the data or adopting non-parametric approaches if normality assumption is violated |
| Change in Grip Strength (Kilogram) | Baseline up to completion of 12 week exercise intervention | Compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. Will initially examine distribution of each outcome variable using Shapiro-Wilk test, as well as data visualization techniques as standard practice. Will consider transforming the data or adopting non-parametric approaches if normality assumption is violated |
| Change in Gait and Balance | Baseline up to completion of 12 week exercise intervention | Measured by mobile sensor. Will compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. Will initially examine distribution of each outcome variable using Shapiro-Wilk test, as well as data visualization techniques as standard practice. Will consider transforming the data or adopting non-parametric approaches if normality assumption is violated |
| Change in Instrumented 6-minute Walk Test | Baseline up to completion of 12 week exercise intervention | Compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. Will initially examine distribution of each outcome variable using Shapiro-Wilk test, as well as data visualization techniques as standard practice. Will consider transforming the data or adopting non-parametric approaches if normality assumption is violated |
| Change in Instrumented Postural Sway | Baseline up to completion of 12 week exercise intervention | Compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. Will initially examine distribution of each outcome variable using Shapiro-Wilk test, as well as data visualization techniques as standard practice. Will consider transforming the data or adopting non-parametric approaches if normality assumption is violated |
| Change in Instrumented Timed up and go Test | Baseline up to completion of 12 week exercise intervention | Compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. Will initially examine distribution of each outcome variable using Shapiro-Wilk test, as well as data visualization techniques as standard practice. Will consider transforming the data or adopting non-parametric approaches if normality assumption is violated |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Supportive Care (Resistance Training, Exercise Counseling) Patients complete a series of progressive resistance training exercises at home twice weekly over 1 hour and receive instructional guidance from an exercise physiologist via videoconferencing once per week during one of these sessions for up to 12 weeks | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Supportive Care (Resistance Training, Exercise Counseling) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Exercise Adherence
Number of participants who completed end-of-intervention assessments and completed at least 18 of 24 prescribed training sessions.
Time frame: From the time of enrollment up to completion of 12 week exercise intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Supportive Care (Resistance Training, Exercise Counseling) | Exercise Adherence | 7 Participants |
Primary
Frequency of Related Serious Adverse Events (SAEs)
Number of participants that experienced exercise-related SAEs
Time frame: From the time of enrollment up to completion of 12 week exercise intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Supportive Care (Resistance Training, Exercise Counseling) | Frequency of Related Serious Adverse Events (SAEs) | 0 Participants |
Primary
Retention
Number of evaluable participants who completed end-of-intervention assessments
Time frame: From the time of enrollment up to 3 months end-of-intervention assessments
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Supportive Care (Resistance Training, Exercise Counseling) | Retention | 9 Participants |
Secondary
Change in Functional Assessment of Chronic Illness Therapy-Fatigue Score (FACT-F)
Fatigue was assessed using the FACT-F scale. This is a 13 item, uni-dimensional, 5-point Likert scale, measuring physical fatigue over the past week. The scale has high internal consistency and is widely used in the literature. Responses range from 0 - 52, with a higher score indicating more fatigue. FACT-F will be summarized as mean and standard deviation. Will also compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function.
Time frame: Baseline up to completion of 12 week exercise intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Supportive Care (Resistance Training, Exercise Counseling) | Change in Functional Assessment of Chronic Illness Therapy-Fatigue Score (FACT-F) | Baseline | 30.2 score on a scale | Standard Deviation 14.8 |
| Supportive Care (Resistance Training, Exercise Counseling) | Change in Functional Assessment of Chronic Illness Therapy-Fatigue Score (FACT-F) | End of Treatment | 40.1 score on a scale | Standard Deviation 10 |
Comparison: Baseline compared to end of 12 week exercise interventionp-value: 0.09Wilcoxon (Mann-Whitney)
Secondary
Change in Gait and Balance
Measured by mobile sensor. Will compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. Will initially examine distribution of each outcome variable using Shapiro-Wilk test, as well as data visualization techniques as standard practice. Will consider transforming the data or adopting non-parametric approaches if normality assumption is violated
Time frame: Baseline up to completion of 12 week exercise intervention
Population: Data could not be collected due to COVID restrictions
Secondary
Change in Godin Leisure-Time Exercise Questionnaire Physical Activity Score (GLTEQ)
To score the GLTEQ, the weekly frequencies of strenuous, moderate, and light activities are multiplied by nine, five, and three, respectively. Total weekly leisure activity is calculated in arbitrary units by summing the products of the separate components as shown in the following formula: Weekly leisure activity score = (9xStrenuous) + (5x Moderate) + (3xLight). Responses range from 0 - greater than 24, with 0 indicating no activity and a higher score indicating more activities (no maximum score). GLTEQ will be summarized as mean and standard deviation. Will also compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function.
Time frame: Baseline up to completion of 12 week exercise intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Supportive Care (Resistance Training, Exercise Counseling) | Change in Godin Leisure-Time Exercise Questionnaire Physical Activity Score (GLTEQ) | Baseline | 28.6 arbitrary units | Standard Deviation 32.9 |
| Supportive Care (Resistance Training, Exercise Counseling) | Change in Godin Leisure-Time Exercise Questionnaire Physical Activity Score (GLTEQ) | End of Treatment | 20.8 arbitrary units | Standard Deviation 12.1 |
Comparison: Baseline compared to end of 12 week exercise interventionp-value: 1Wilcoxon (Mann-Whitney)
Secondary
Change in Grip Strength (Kilogram)
Compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. Will initially examine distribution of each outcome variable using Shapiro-Wilk test, as well as data visualization techniques as standard practice. Will consider transforming the data or adopting non-parametric approaches if normality assumption is violated
Time frame: Baseline up to completion of 12 week exercise intervention
Population: Data could not be collected due to COVID restrictions
Secondary
Change in Instrumented 6-minute Walk Test
Compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. Will initially examine distribution of each outcome variable using Shapiro-Wilk test, as well as data visualization techniques as standard practice. Will consider transforming the data or adopting non-parametric approaches if normality assumption is violated
Time frame: Baseline up to completion of 12 week exercise intervention
Population: Data could not be collected due to COVID restrictions
Secondary
Change in Instrumented Postural Sway
Compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. Will initially examine distribution of each outcome variable using Shapiro-Wilk test, as well as data visualization techniques as standard practice. Will consider transforming the data or adopting non-parametric approaches if normality assumption is violated
Time frame: Baseline up to completion of 12 week exercise intervention
Population: Data could not be collected due to COVID restrictions
Secondary
Change in Instrumented Timed up and go Test
Compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. Will initially examine distribution of each outcome variable using Shapiro-Wilk test, as well as data visualization techniques as standard practice. Will consider transforming the data or adopting non-parametric approaches if normality assumption is violated
Time frame: Baseline up to completion of 12 week exercise intervention
Population: Data could not be collected due to COVID restrictions
Secondary
Change in Short Form-36 Physical Function Score
The 36-Item Short Form Health Survey (SF-36) consists of a set of generic, quality-of-life measures to survey physical function in the general population. Responses range from 0 - 100, with a higher score indicating a more favorable health state. Will be summarized as mean and standard deviation. Will also compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function.
Time frame: Baseline up to completion of 12 week exercise intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Supportive Care (Resistance Training, Exercise Counseling) | Change in Short Form-36 Physical Function Score | Baseline | 43.3 score on a scale | Standard Deviation 8.4 |
| Supportive Care (Resistance Training, Exercise Counseling) | Change in Short Form-36 Physical Function Score | End of Treatment | 49.1 score on a scale | Standard Deviation 6.7 |
Comparison: Baseline compared to end of 12 week exercise interventionp-value: 0.02Wilcoxon (Mann-Whitney)
Secondary
Change in Short Physical Performance Battery Score
Compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. Will initially examine distribution of each outcome variable using Shapiro-Wilk test, as well as data visualization techniques as standard practice. Will consider transforming the data or adopting non-parametric approaches if normality assumption is violated
Time frame: Baseline up to completion of 12 week exercise intervention
Population: Data could not be collected due to COVID restrictions
Secondary
Difference in 1-repetition Maximum (Kilogram)
Compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. Will initially examine distribution of each outcome variable using Shapiro-Wilk test, as well as data visualization techniques as standard practice. Will consider transforming the data or adopting non-parametric approaches if normality assumption is violated.
Time frame: Baseline up to completion of 12 week exercise intervention
Population: Data could not be collected due to COVID restrictions
Secondary
Individualized Progressive Resistance Training (PRT) Prescriptions
Number of participants who received an individualized PRT prescription developed for the participant by the study exercise physiologist.
Time frame: From the time of enrollment up to completion of 12 week exercise intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Supportive Care (Resistance Training, Exercise Counseling) | Individualized Progressive Resistance Training (PRT) Prescriptions | 10 Participants |
Secondary
Mean Patient-Reported Outcomes Measurement Information System (PROMIS) - Cancer Physical Function Score Value
The PROMIS-Cancer assessment consists of 45 questions pertaining to physical function, each of which are designed as having five-point ordinal rating scales. Participants are asked to respond to questions regarding the extent of their physical function. Responses range from 1 to 5, where 1 represents unable to do and 5 represents without any difficulty. Each PROMIS assessment generates a T-score, which is a standardized score with a mean of 50 and standard deviation of 10 in a reference population of cancer patients, i.e., a score of 40 is one SD lower than the mean of the reference population. A PROMIS-Cancer Physical Function score less than 50 indicates patient-reported physical function worse than the cancer patient mean. The PROMIS T-scores are summarized with mean and standard deviation, with comparison of scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function.
Time frame: Baseline up to completion of 12 week exercise intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Supportive Care (Resistance Training, Exercise Counseling) | Mean Patient-Reported Outcomes Measurement Information System (PROMIS) - Cancer Physical Function Score Value | Baseline | 45.6 score on a scale | Standard Deviation 9.4 |
| Supportive Care (Resistance Training, Exercise Counseling) | Mean Patient-Reported Outcomes Measurement Information System (PROMIS) - Cancer Physical Function Score Value | End of Treatment | 47.2 score on a scale | Standard Deviation 8.2 |
Comparison: Baseline compared to end of 12 week exercise interventionp-value: 0.59Wilcoxon (Mann-Whitney)