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Cancer SurvivorNCT02268188

Harvesting Health Program in Improving Diet and Physical Activity Level in Cancer Survivors

A study testing education, nutrition intervention and exercise intervention in people with Cancer Survivor, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This pilot clinical trial studies the Harvesting Health Program in improving the diet and physical activity level of cancer survivors. Nutrition and physical activity classes and the opportunity to harvest fruits, vegetables, and herbs may increase participants' fruit and vegetable consumption and physical activity… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cancer Survivor
What is being tested?
education, nutrition intervention and exercise intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
Apr 2014to 31 Oct 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Voluntary agreement to participate and sign an informed consent document
  • Adults with the ability to read, write, and speak English who have access to the internet
  • Cancer survivors who have completed active cancer treatments within the previous 12 months extended-stage survivors)
  • Survivors must have a computer with internet access and an active email account
  • Participants must refrain from traveling for more than 3 weeks total during the intervention period
  • Participants who are undergoing long-term hormone therapy (i.e., tamoxifen) are permitted to enroll

Who cannot join

  • Cancer survivors who are cognitively unable to consent or have physical or mental limitations that would prevent full participation in the program
  • Adults receiving active treatment including surgery, neoadjuvant hormonal, chemotherapy, or radiation
  • Survivors with pre-existing medical conditions that preclude unsupervised physical activity (i.e., severe orthopedic conditions, impending hip or knee replacement, paralysis, unstable angina, dementia, or recent history of myocardial infarction, congestive heart failure, pulmonary conditions that require oxygen, or hospitalization within six months)
  • Adults taking any medication that do not allow for increased intake of fruits and vegetables (i.e., pharmacologic doses of warfarin)
  • Survivors currently involved in other clinical trials
  • Long-term cancer survivors (> 12 months post treatment)
Show all 9Show fewer
  • Those planning to start certain medications after the trial enrollment or use of non- prescription substances (i.e. saw palmetto and other herbal or alternative products)
  • Survivors with active metabolic or digestive illnesses such as malabsorptive disorders (Crohn's, celiac disease, irritable bowel syndrome [IBS]), renal insufficiency, hepatic insufficiency, cachexia, or short bowel syndrome
  • Pregnant women will be excluded from the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Harvesting Health for Cancer Survivors: A Pilot Project

This pilot clinical trial studies the Harvesting Health Program in improving the diet and physical activity level of cancer survivors. Nutrition and physical activity classes and the opportunity to harvest fruits, vegetables, and herbs may increase participants' fruit and vegetable consumption and physical activity levels. Studying the participation rates and changes in participants' eating and physical activity habits may help doctors learn whether the program has an effect on participant lifestyle.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Measure survivor participation in regards to each aspect of the Harvesting Health Program (personalized and group education, gardening and harvesting, and utilization of novel web-based technologies).

II. Assess survivor preferences regarding key Harvesting Health Program components impacting participation (physical facilities, schedule and timing, education topics and sessions, garden access, web portal usability, etc.).

SECONDARY OBJECTIVES:

  1. A customized "Nutrition \& Physical Activity Scorecard" has been developed and will be implemented to evaluate pre/post measures of diet and physical activity at baseline (month 0) and at months 6, 9 and 12.

II. Participants are evaluated at baseline and at completion of the intervention for: (a) serum and body composition biomarkers of exposure and efficacy, and (b) health indices related to cancer survivorship and overall health.

III. To assess Program sustainability, follow-up questionnaires will be completed at 9 and 12 months using the Nutrition \& Physical Activity Scorecard and questionnaires regarding quality of life outcomes.

OUTLINE:

Participants undergo a series of 10 education and training sessions over 1 hour every 2 weeks, comprising education on current research, evidence-based health guidelines, application techniques, reference materials specific to extended-stage cancer survivors, and recommendations and personal health goals for survivorship.

Conditions
Cancer Survivor
Being tested
education, nutrition intervention, exercise intervention, questionnaire administration, laboratory biomarker analysis
Keywords
Cancer Survivors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • educationOther

    Attend classes as part of Harvesting Health program

  • nutrition interventionOther

    Learn how to incorporate nutrition guidelines into daily meal plans as part of Harvesting Health program

  • exercise interventionBehavioural

    Use FitBit to log daily steps as part of Harvesting Health program

  • questionnaire administrationOther

    Ancillary studies

  • laboratory biomarker analysisOther

    Correlative studies

  • quality-of-life assessmentOther

    Also called quality of life assessment

    Ancillary studies

Study groups in NCT02268188
Study groupRoleWhat they receive
Supportive Care (Harvesting Health program)ExperimentalParticipants undergo a series of 10 education and training sessions over 1 hour every 2 weeks, comprising education on current research, evidence-based health guidelines, application techniques, reference materials specific to extended-stage cancer survivors, and recommendations and personal health goals for survivorship. The guidelines described in class are part of a nutrition intervention and an exercise intervention with personal and group goal setting over the course of the study.
Receives: Other: education; Other: nutrition intervention; Behavioral: exercise intervention; Other: questionnaire administration; Other: laboratory biomarker analysis; Other: quality-of-life assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of sessions attended, as measured by mobile scanner

    Analyzed with standard descriptive statistics. Measures of central tendency (mean and/or median) and spread (standard deviation, quartiles, minimum and maximum) will be reported.

    Measured: Up to 6 months

  2. Number of hits on the web portal

    Analyzed with standard descriptive statistics. Measures of central tendency (mean and/or median) and spread (standard deviation, quartiles, minimum and maximum) will be reported.

    Measured: Up to 12 months

Secondary outcomes (6)

  1. Number of web hits on portal pages

    Quantitative and qualitative analysis will be performed on the harvest log to determine common themes and feedback from the participants.

    Measured: Up to 12 months

  2. Program evaluation overall score

    Quantitative and qualitative analysis will be performed on the harvest log to determine common themes and feedback from the participants.

    Measured: Up to 20 weeks

  3. Change in behavior, measured by Nutrition & Physical Activity Scorecards

    The hypothesis of no change in the overall scorecard value will be tested versus a two sided alternative using a paired T-test at alpha level 0.025 (Bonferroni corrected for 2 scorecards). Exploratory analyses may be completed to understand which components of these Scorecards are driving the improvement or degradation in scores.

    Measured: Baseline to 12 months

  4. Change in biomarker levels, assessed by values for the Health & Wellness Index

    Biomarkers include blood glucose, lipid panel (total cholesterol, high-density lipoprotein, low-density lipoprotein, triglycerides), skin antioxidant score and bone density. The hypothesis of no change in these markers will be tested using a multivariate Hotelling's T-squared test at the 0.05 level. If a significant difference is noted, then the individual scores will be further tested with paired t-tests to determine which are significantly different. The p-values of the individual t-tests will be adjusted via a Bonferroni correction.

    Measured: Baseline to 6 months

  5. Change in physical activity using the International Physical Activity Questionnaire

    This questionnaire categorizes respondents into "Low", "Moderate", or "High" activity levels based upon survey responses.

    Measured: Baseline to 12 months

  6. Change in nutrient intake

    Viowell food frequency questionnaire

    Measured: Baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionOct 2015
  4. Study completion31 Oct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02268188
Sponsor's protocol ID
OSU-14013
Other IDs
NCI-2014-01498
Status last verified
Aug 2019
First submitted
15 Oct 2014
Last updated
30 Aug 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Spees CK, Braun AC, Hill EB, Grainger EM, Portner J, Young GS, Kleinhenz MD, Chitchumroonchokchai C, Clinton SK. Impact of a Tailored Nutrition and Lifestyle Intervention for Overweight Cancer Survivors on Dietary Patterns, Physical Activity, Quality of Life, and Cardiometabolic Profiles. J Oncol. 2019 Nov 21;2019:1503195. doi: 10.1155/2019/1503195. eCollection 2019.

    PubMed 31871455

Questions about this trial

What is this clinical trial studying?

A study testing education, nutrition intervention and exercise intervention in people with Cancer Survivor, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of sessions attended, as measured by mobile scanner (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02268188, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2019.

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