Cancer SurvivorNCT03063918
Personalized Dietary Intervention in Managing Bowel Dysfunction and Improving Quality of Life in Stage I-III Rectosigmoid Cancer Survivors
A study testing Informational Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Cancer Survivor and Stage I Rectosigmoid Cancer, run by City of Hope Medical Center at 2 sites in United States.
Trial summary
This pilot clinical trial studies how well personalized dietary intervention works in managing bowel dysfunction and improving quality of life in stage I-III rectosigmoid cancer survivors. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cancer Survivor, Stage I Rectosigmoid Cancer, Stage II Rectosigmoid Cancer
- What is being tested?
- Informational Intervention, Quality-of-Life Assessment and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Apr 2017to 7 Sep 2021
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of stage I-III cancers of the rectosigmoid colon or rectum
- 6 months post-treatment completion
- Have a permanent ostomy or anastomosis
- English-speaking
- All subjects must have the ability to understand and the willingness to sign a written informed consent
Who cannot join
- Patients with stage IV disease will be excluded from the study
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
City of Hope Medical Center
Duarte, California, 91010
The University of Arizona Medical Center-University Campus
Tucson, Arizona, 85724
About this study
Official title: Pilot Study of a Personalized Dietary Intervention to Manage Bowel Dysfunction in Rectal Cancer Survivors
This pilot clinical trial studies how well personalized dietary intervention works in managing bowel dysfunction and improving quality of life in stage I-III rectosigmoid cancer survivors. Personalized dietary intervention may help people understand bowel symptoms, identify helpful and troublesome foods for bowel symptoms, adjust diets and food preparation based on food triggers, and coach on healthy diet recommendations after cancer treatment.
Read the detailed description
PRIMARY OBJECTIVES:
- Administer and determine the feasibility of the personalized dietary intervention.
II. Using qualitative methods, evaluate the acceptability of the intervention as reported by survivors.
III. Explore decisional conflict associated with treatment decision-making in rectal cancer surgery.
OUTLINE:
At 6 months after standard of care treatment, patients receive 10 sessions of personalized dietary intervention over 30 minutes each over 4 months via the telephone. Patients also receive a workbook including reference materials and intervention content.
After completion of study, patients are followed up for 6 months.
- Conditions
- Cancer Survivor, Stage I Rectosigmoid Cancer, Stage II Rectosigmoid Cancer, Stage III Rectosigmoid Cancer
- Being tested
- Informational Intervention, Quality-of-Life Assessment, Questionnaire Administration, Survey Administration, Telephone-Based Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informational InterventionOther
Receive a workbook
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Survey AdministrationOther
Ancillary studies
Telephone-Based InterventionBehavioural
Receive personalized dietary intervention
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (personalized dietary intervention) | Experimental | At 6 months after standard of care treatment, patients receive 10 sessions of personalized dietary intervention over 30 minutes each over 4 months via the telephone. Patients also receive a workbook including reference materials and intervention content. Receives: Other: Informational Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration; Behavioral: Telephone-Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability assessed by semi-structured interview
Will be assessed through qualitative data analysis using conventional content analysis approach.
Measured: Up to 6 months
Bowel function assessed by Memorial Sloan Kettering Cancer Center Bowel Function Tool
Descriptive statistics will be summarized using validated scoring procedures.
Measured: Up to 6 months
Feasibility assessed by patient enrollment
Will be assessed through: 1) the ratio of eligible participants to those enrolled and those who declines participation; 2) reasons for non-participation; 3) number of scheduled study encounters completed; 4) attrition rate between pre- and post-intervention; 5) reasons for attrition/dropout; 6) level of intervention participation including the total number of sessions, number of sessions completed without break-offs, number of break-offs, length (minutes) of sessions; and 7) the ratio of all participants to those who complete >= 80% of the study.
Measured: Up to 6 months
Quality of life assessed by City of Hope-Quality of Life-Colorectal Cancer
Descriptive statistics will be summarized using validated scoring procedures.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start28 Apr 2017
- Primary completion7 Sep 2021
- Study completion7 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Hope Foundation
- Responsible party
- Sponsor
- Investigators
- Virginia Sun, PhD, RN, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063918
- Sponsor's protocol ID
- 16332
- Other IDs
- NCI-2017-00258, 16332
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2017
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Personalized Dietary Intervention to Manage Bowel Dysfunction in Rectal Cancer Survivors
- ClinicalTrials.gov ID
- NCT03063918
- Acronym / sponsor ID
- 16332
- Conditions
- Cancer Survivor, Stage I Rectosigmoid Cancer, Stage II Rectosigmoid Cancer, Stage III Rectosigmoid Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Hope Foundation
- Study start
- 28 Apr 2017 (actual)
- Primary completion
- 7 Sep 2021 (actual)
- Study completion
- 7 Sep 2021 (actual)
- First posted
- 24 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot clinical trial studies how well personalized dietary intervention works in managing bowel dysfunction and improving quality of life in stage I-III rectosigmoid cancer survivors. Personalized dietary intervention may help people understand bowel symptoms, identify helpful and troublesome foods for bowel symptoms, adjust diets and food preparation based on food triggers, and coach on healthy diet recommendations after cancer treatment.
Detailed description
PRIMARY OBJECTIVES:
- Administer and determine the feasibility of the personalized dietary intervention.
II. Using qualitative methods, evaluate the acceptability of the intervention as reported by survivors.
III. Explore decisional conflict associated with treatment decision-making in rectal cancer surgery.
OUTLINE:
At 6 months after standard of care treatment, patients receive 10 sessions of personalized dietary intervention over 30 minutes each over 4 months via the telephone. Patients also receive a workbook including reference materials and intervention content.
After completion of study, patients are followed up for 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (personalized dietary intervention) | Experimental | Other: Informational Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Other: Survey Administration, Behavioral: Telephone-Based InterventionAt 6 months after standard of care treatment, patients receive 10 sessions of personalized dietary intervention over 30 minutes each over 4 months via the telephone. Patients also receive a workbook including reference materials and intervention content. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of stage I-III cancers of the rectosigmoid colon or rectum
- 6 months post-treatment completion
- Have a permanent ostomy or anastomosis
- English-speaking
- All subjects must have the ability to understand and the willingness to sign a written informed consent
Key exclusion criteria (2 listed)
- Patients with stage IV disease will be excluded from the study
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Informational InterventionReceive a workbook | Other | Supportive Care (personalized dietary intervention) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive Care (personalized dietary intervention) |
| Questionnaire AdministrationAncillary studies | Other | Supportive Care (personalized dietary intervention) |
| Survey AdministrationAncillary studies | Other | Supportive Care (personalized dietary intervention) |
| Telephone-Based InterventionReceive personalized dietary intervention | Behavioural | Supportive Care (personalized dietary intervention) |
Primary outcome
Acceptability assessed by semi-structured interview
Time frame: Up to 6 months
Will be assessed through qualitative data analysis using conventional content analysis approach.
Bowel function assessed by Memorial Sloan Kettering Cancer Center Bowel Function Tool
Time frame: Up to 6 months
Descriptive statistics will be summarized using validated scoring procedures.
Feasibility assessed by patient enrollment
Time frame: Up to 6 months
Will be assessed through: 1) the ratio of eligible participants to those enrolled and those who declines participation; 2) reasons for non-participation; 3) number of scheduled study encounters completed; 4) attrition rate between pre- and post-intervention; 5) reasons for attrition/dropout; 6) level of intervention participation including the total number of sessions, number of sessions completed without break-offs, number of break-offs, length (minutes) of sessions; and 7) the ratio of all participants to those who complete >= 80% of the study.
Quality of life assessed by City of Hope-Quality of Life-Colorectal Cancer
Time frame: Up to 6 months
Descriptive statistics will be summarized using validated scoring procedures.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginia Sun, PhD, RN principal investigator
City of Hope Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Informational Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Cancer Survivor and Stage I Rectosigmoid Cancer, run by City of Hope Medical Center at 2 sites 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 5 inclusion and 2 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 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Acceptability assessed by semi-structured interview (time frame: Up to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Feb 2024.