Cancer Survivor
Conditions
Brief summary
Harvest for Health is a home-based vegetable gardening intervention that pairs cancer survivors with certified master gardeners (MGs) from the Cooperative Extension System, the education and outreach arm of land-grant universities nationwide.
Detailed description
Few lifestyle behavior change interventions have been successfully translated into practice. Addressing this research-to-practice gap is a significant research and public health priority. Harvest for Health is a home-based vegetable gardening intervention that pairs cancer survivors with certified Master Gardeners from the Cooperative Extension System. The parent study was started at the University of Alabama at Birmingham and is currently being conducted throughout the entire state of Alabama. Preliminary findings suggest that this intervention increases vegetable consumption and physical activity, and improves physical functioning and health-related quality of life. We propose a feasibility study to adapt this promising program to the multi-cultural population of cancer survivors and for the local context (physical, social, and cultural environment) of New Mexico. We will then implement the adapted program, Southwest Harvest for Health and evaluate feasibility, acceptability, and fidelity. The adaptation phase is a critical first step towards widespread dissemination, implementation, and scale-up of an evidence-based intervention.
Interventions
BEHAVIORALhome-based, mentored vegetable gardening program
The mentored vegetable gardening program pairs each participant with a certified Master Gardener. The participant/Master Gardener dyads work together to plan, plant and tend to a vegetable garden at the participant's home throughout the year. Gardening supplies, plants and seeds are provided.
Sponsors
University of New Mexico Cancer Center
New Mexico State University
University of New Mexico
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 50 years or older * Residing in Bernalillo or Sandoval County, New Mexico * Diagnosed with an invasive cancer (any type) * Completed primary treatment (surgery, radiation, chemotherapy)(note: endocrine therapy is allowed) * Able to read, speak, and understand English (The future larger trial will include Spanish-Speaking participants) * Not told by a physician to limit physical activity and no pre-existing medical condition(s) that would preclude home gardening, e.g., severe orthopedic conditions, hip or knee replacement surgery within 6 months), end-stage renal disease, paralysis, dementia, blindness, unstable angina, untreated stage 3 hypertension, or recent history of myocardial infarction, congestive heart failure, or pulmonary conditions that required oxygen or hospitalization within 6 months. * Currently not adhering to the recommended number of fruit and vegetable servings per day (consuming fewer than 5 servings of vegetables and fruits/day and not meeting the recommended guidelines for moderate-to-vigorous physical activity (\< 150 minutes/week) * Reside in a location that can accommodate a 4' x 8' raised garden bed or 4 (29 x 14) garden containers, or adequate (at least 4 hours) of sunlight per day and have access to running water * No existing or recent (within the past year) experience with vegetable gardening * Able to participate in the 10-month intervention (all three seasonal gardens; from mid-February through early November 2020)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the Intervention | through study completion, an average of 9 months | Ability to recruit 25 cancer survivors in 3 months, achieve 80% retention rates, 80% adherence to the intervention, and high acceptability of the program for both cancer survivors (participants) and Cooperative Extension Master Gardeners. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pre-post Change in Vegetable and Fruit Intake | baseline to 9-months | The number of daily servings of vegetables and fruits will be measured by the Eating at America's Table Screener (EATS) questionnaire; this 10-item NCI-developed questionnaire will be able to assess whether individuals increase by more than one serving of vegetables/fruits per day. |
| Pre-post Change in Objectively Measured Physical Activity | baseline to 9-months | Physical activity will be objectively measured using the activPAL research grade monitor. |
| Pre-post Change in Sleep Quality | baseline to 9-months | Self-reported sleep quality will be assessed using the PROMIS 8-item questionnaires for sleep impairment and sleep disturbance. Raw scores range from 8 to 40; higher scores indicate worse sleep quality; T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. |
| Pre-post Change in Physical Function | baseline to 9-months | Self-reported physical function will be assessed using the 8-item physical function scale. Raw scores range from 8 to 40; higher scores indicate better physical function; T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. |
| Pre-post Change in Physical Performance | baseline to 9-months | Physical performance will be objectively measured using the Rikli & Jones Senior Fitness Battery. |
Countries
United States
Participant flow
Recruitment details
Distributed recruitment flyers in community locations, e.g., cancer survivor support groups, community centers. Also, oncologists, physicians, and nurse navigators referred patients (cancer survivors). Self-referrals. Note: Master Gardeners are not participants; they were not enrolled and consented, nor did they complete outcome assessments; instead, they are volunteers from the Extension Master Gardener Program who delivered the interention.
Participants by arm
| Arm | Count |
|---|---|
| Single Arm All participants will receive the 10-month mentored, vegetable gardening intervention
home-based, mentored vegetable gardening program: The mentored vegetable gardening program pairs each participant with a certified Master Gardener. The participant/Master Gardener dyads work together to plan, plant and tend to a vegetable garden at the participant's home throughout the year. Gardening supplies, plants and seeds are provided. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Continuous | 68 years STANDARD_DEVIATION 7.2 |
| Race/Ethnicity, Customized Hispanic White | 6 participants |
| Race/Ethnicity, Customized Non-Hispanic White | 22 participants |
| Race/Ethnicity, Customized Other | 2 participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Feasibility of the Intervention
Ability to recruit 25 cancer survivors in 3 months, achieve 80% retention rates, 80% adherence to the intervention, and high acceptability of the program for both cancer survivors (participants) and Cooperative Extension Master Gardeners.
Time frame: through study completion, an average of 9 months
Population: (1) Percentage of participants recruited within 3 months; (2) percentage of participants who completed the study; (3) percentage of participants adhering to twice monthly communication with Master Gardener mentor; (4) percentage rating their experience with the intervention as very good or excellent.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Arm | Feasibility of the Intervention | Percentage recruited within 3 months | 100 percentage of participants |
| Single Arm | Feasibility of the Intervention | Percent retention (completed study) | 100 percentage of participants |
| Single Arm | Feasibility of the Intervention | Percentage adherence (twice monthly communication with mentor) | 89 percentage of participants |
| Single Arm | Feasibility of the Intervention | Percentage Satisfaction (very good or excellent) | 90 percentage of participants |
Secondary
Pre-post Change in Objectively Measured Physical Activity
Physical activity will be objectively measured using the activPAL research grade monitor.
Time frame: baseline to 9-months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Single Arm | Pre-post Change in Objectively Measured Physical Activity | light-intensity physical activity | -1.1 minutes per day |
| Single Arm | Pre-post Change in Objectively Measured Physical Activity | moderate-intensity physical activity | -4.2 minutes per day |
Secondary
Pre-post Change in Physical Function
Self-reported physical function will be assessed using the 8-item physical function scale. Raw scores range from 8 to 40; higher scores indicate better physical function; T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.
Time frame: baseline to 9-months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Single Arm | Pre-post Change in Physical Function | 0.0 change in points |
Secondary
Pre-post Change in Physical Performance
Physical performance will be objectively measured using the Rikli & Jones Senior Fitness Battery.
Time frame: baseline to 9-months
Population: Due to the COVID-19 pandemic, the in-person assessment of physical performance was dropped. Studies at the University of New Mexico were not allowed to conduct in-person assessments in 2020 after the pandemic was declared. Therefore, no post-intervention data on physical performance was collected (for any participant), and it is not possible to calculate change in physical performance. Only baseline physical performance data was collected.
Secondary
Pre-post Change in Sleep Quality
Self-reported sleep quality will be assessed using the PROMIS 8-item questionnaires for sleep impairment and sleep disturbance. Raw scores range from 8 to 40; higher scores indicate worse sleep quality; T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.
Time frame: baseline to 9-months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Single Arm | Pre-post Change in Sleep Quality | Sleep disturbance | -0.4 change in points |
| Single Arm | Pre-post Change in Sleep Quality | Sleep impairment | -0.2 change in points |
Secondary
Pre-post Change in Vegetable and Fruit Intake
The number of daily servings of vegetables and fruits will be measured by the Eating at America's Table Screener (EATS) questionnaire; this 10-item NCI-developed questionnaire will be able to assess whether individuals increase by more than one serving of vegetables/fruits per day.
Time frame: baseline to 9-months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Single Arm | Pre-post Change in Vegetable and Fruit Intake | 1.2 fruit & vegetable servings/day |