Rectal CancerNCT06435975
Physical Activity in Rectal Cancer Survivors
A study testing Physical Activity, Survey and Telehealth Lifestyle Coaching in people with Rectal Cancer and Rectosigmoid Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
The goal of this clinical trial is to test a telehealth-based personalized physical activity intervention in adult patients diagnosed with Stage I-III rectal cancer. The main question it aims to answer are how to better understand the experiences of rectal cancer survivors who are coping with bowel dysfunction and how… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Rectosigmoid Cancer
- What is being tested?
- Physical Activity, Survey and Telehealth Lifestyle Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 6 Mar 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Stage I-III cancers of the rectum/rectosigmoid.
- Age 18 or older
- Three months to 5 years post-treatment completion
- Have a rectal or anal anastomosis with a LARS score of 21-42
- At least 10 participants must be racial/ethnic minority (Black/African American, Hispanic/Latino)
- Ability to be physically active and cleared by MD
Show all 9Show fewer
- Patients must be able to read and understand English.
- Participants must sign the informed consent form
- The study is open to anyone regardless of gender or ethnicity. Efforts will be made to extend the accrual to a representative population, but in a trial which will accrue 20 subjects, a balance must be struck between subject safety considerations and limitations on the number of individuals exposed to potentially toxic or ineffective treatments on the one hand and the need to explore gender, racial, and ethnic aspects of clinical research on the other. If differences in outcome that correlate to gender, racial, or ethnic identity are noted, accrual may be expanded, or additional studies may be performed to investigate those differences more fully.
Who cannot join
- 1. Patients failing to meet all the above inclusion criteria will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Pilot Study of Physical Activity Intervention to Manage Bowel Dysfunction in Rectal Cancer Survivors
The goal of this clinical trial is to test a telehealth-based personalized physical activity intervention in adult patients diagnosed with Stage I-III rectal cancer. The main question it aims to answer are how to better understand the experiences of rectal cancer survivors who are coping with bowel dysfunction and how physical activity can improve their quality of life.
Participants will be asked to:
- Complete surveys to assess bowel function and quality of life
- Participate in 12 Telehealth Sessions (one session a week) to discuss and review bowel dysfunction
- Perform daily physical activity
Read the detailed description
The goal of this clinical trial is to administer and determine the feasibility of a personalized physical activity intervention for rectal cancer survivors. Structured physical activity interventions will be administered over a three-month period. An exit interview will be conducted at the completion of this time period.
- Conditions
- Rectal Cancer, Rectosigmoid Cancer
- Being tested
- Physical Activity, Survey, Telehealth Lifestyle Coaching
- Keywords
- Rectal Cancer, Physical Activity, Bowel Dysfunction, Telehealth
- Medical subject headings
- Rectal Neoplasms, Motor Activity, Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityOther
Participants will perform a baseline +4000 steps/day for the duration of the study. Aerobic exercise, similar to a brisk walk, will be recommended as the primary mode of exercise.
SurveyOther
Participants will complete a series of survey at multiple points throughout this study to assess quality of life issues. Questionnaires may be completed via paper forms with prepaid postage envelopes or using a REDCap online survey.
Telehealth Lifestyle CoachingBehavioural
Participants will meet with a health coach, the Principal Investigator, to review baseline bowel habits and symptoms as well as discuss physical activity and potential strategies to achieve this goal, on a weekly basis for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Participants in this arm will be asked to complete a series of surveys, participate in telehealth-based interventions, and engage in moderate physical activity. Receives: Other: Physical Activity; Other: Survey; Behavioral: Telehealth Lifestyle Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Physical Activity Intervention
Administer and determine the feasibility of a PA intervention. We will administer a telehealth physical activity intervention to 20 RC survivors (10 males and 10 females, at least 10 of which will be racial and/or ethnic minorities) over 12 weeks. Feasibility of the intervention will be measured by the percentage of participants who agree to participate of the total approached as well as completion of the intervention which will be defined as completion of ≥80% of the intervention (telehealth calls).
Measured: From enrollment to the end of treatment at 12 weeks.
Secondary outcomes (2)
Acceptability and Participant Satisfaction with Physical Activity Intervention
Using qualitative methods, evaluate the acceptability of and satisfaction with the intervention as reported by survivors. After completion of the intervention or decision to discontinue participation, we will administer a semi-structured exit interview to evaluate the acceptability of the intervention.
Measured: From enrollment to the end of treatment after 12 weeks.
Evaluation using Memorial Sloan Kettering Cancer Center Bowel Function Instrument Scale to describe the change in total bowel symptom score in the pilot cohort from minimum score of 13 to maximum score of 65, where the higher score is the better outcome.
Using the Memorial Sloan Kettering bowel function instrument administered pre-post PA intervention, describe the change in total bowel symptom score in the pilot cohort.
Measured: At 0 weeks, 3 weeks, and 6 months after completion of the initial intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 Jun 2022
- Primary completion6 Mar 2024
- Study completion6 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erica Pettke, MD, MPH, FACS, Abramson Cancer Center at Penn Medicine
- Investigators
- Erica Pettke, MD, MPH, FACS, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435975
- Sponsor's protocol ID
- UPCC 20221
- Other IDs
- 849585
- Status last verified
- May 2024
- First submitted
- 6 May 2024
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hendren SK, O'Connor BI, Liu M, Asano T, Cohen Z, Swallow CJ, Macrae HM, Gryfe R, McLeod RS. Prevalence of male and female sexual dysfunction is high following surgery for rectal cancer. Ann Surg. 2005 Aug;242(2):212-23. doi: 10.1097/01.sla.0000171299.43954.ce.
PubMed 16041212Lange MM, van de Velde CJ. Urinary and sexual dysfunction after rectal cancer treatment. Nat Rev Urol. 2011 Jan;8(1):51-7. doi: 10.1038/nrurol.2010.206. Epub 2010 Dec 7.
PubMed 21135876Bruheim K, Guren MG, Skovlund E, Hjermstad MJ, Dahl O, Frykholm G, Carlsen E, Tveit KM. Late side effects and quality of life after radiotherapy for rectal cancer. Int J Radiat Oncol Biol Phys. 2010 Mar 15;76(4):1005-11. doi: 10.1016/j.ijrobp.2009.03.010. Epub 2009 Jun 18.
PubMed 19540058Hoerske C, Weber K, Goehl J, Hohenberger W, Merkel S. Long-term outcomes and quality of life after rectal carcinoma surgery. Br J Surg. 2010 Aug;97(8):1295-303. doi: 10.1002/bjs.7105.
PubMed 20602501Sun V, Grant M, Wendel CS, McMullen CK, Bulkley JE, Altschuler A, Ramirez M, Baldwin CM, Herrinton LJ, Hornbrook MC, Krouse RS. Dietary and Behavioral Adjustments to Manage Bowel Dysfunction After Surgery in Long-Term Colorectal Cancer Survivors. Ann Surg Oncol. 2015 Dec;22(13):4317-24. doi: 10.1245/s10434-015-4731-9. Epub 2015 Jul 10.
PubMed 26159443Krouse RS, Wendel CS, Garcia DO, Grant M, Temple LKF, Going SB, Hornbrook MC, Bulkley JE, McMullen CK, Herrinton LJ. Physical activity, bowel function, and quality of life among rectal cancer survivors. Qual Life Res. 2017 Nov;26(11):3131-3142. doi: 10.1007/s11136-017-1641-2. Epub 2017 Jul 4.
PubMed 28677077Fong DY, Ho JW, Hui BP, Lee AM, Macfarlane DJ, Leung SS, Cerin E, Chan WY, Leung IP, Lam SH, Taylor AJ, Cheng KK. Physical activity for cancer survivors: meta-analysis of randomised controlled trials. BMJ. 2012 Jan 30;344:e70. doi: 10.1136/bmj.e70.
PubMed 22294757Denlinger CS, Engstrom PF. Colorectal cancer survivorship: movement matters. Cancer Prev Res (Phila). 2011 Apr;4(4):502-11. doi: 10.1158/1940-6207.CAPR-11-0098.
PubMed 21464030Rock CL, Doyle C, Demark-Wahnefried W, Meyerhardt J, Courneya KS, Schwartz AL, Bandera EV, Hamilton KK, Grant B, McCullough M, Byers T, Gansler T. Nutrition and physical activity guidelines for cancer survivors. CA Cancer J Clin. 2012 Jul-Aug;62(4):243-74. doi: 10.3322/caac.21142. Epub 2012 Apr 26.
PubMed 22539238Grimmett C, Bridgewater J, Steptoe A, Wardle J. Lifestyle and quality of life in colorectal cancer survivors. Qual Life Res. 2011 Oct;20(8):1237-45. doi: 10.1007/s11136-011-9855-1. Epub 2011 Feb 1.
PubMed 21286822Brown JC, Schmitz KH. The prescription or proscription of exercise in colorectal cancer care. Med Sci Sports Exerc. 2014 Dec;46(12):2202-9. doi: 10.1249/MSS.0000000000000355.
PubMed 24781887Kushi LH, Doyle C, McCullough M, Rock CL, Demark-Wahnefried W, Bandera EV, Gapstur S, Patel AV, Andrews K, Gansler T; American Cancer Society 2010 Nutrition and Physical Activity Guidelines Advisory Committee. American Cancer Society Guidelines on nutrition and physical activity for cancer prevention: reducing the risk of cancer with healthy food choices and physical activity. CA Cancer J Clin. 2012 Jan-Feb;62(1):30-67. doi: 10.3322/caac.20140.
PubMed 22237782Ottenbacher A, Yu M, Moser RP, Phillips SM, Alfano C, Perna FM. Population Estimates of Meeting Strength Training and Aerobic Guidelines, by Gender and Cancer Survivorship Status: Findings From the Health Information National Trends Survey (HINTS). J Phys Act Health. 2015 May;12(5):675-9. doi: 10.1123/jpah.2014-0003. Epub 2014 May 15.
PubMed 24834485Bellizzi KM, Rowland JH, Jeffery DD, McNeel T. Health behaviors of cancer survivors: examining opportunities for cancer control intervention. J Clin Oncol. 2005 Dec 1;23(34):8884-93. doi: 10.1200/JCO.2005.02.2343.
PubMed 16314649Courneya KS, Katzmarzyk PT, Bacon E. Physical activity and obesity in Canadian cancer survivors: population-based estimates from the 2005 Canadian Community Health Survey. Cancer. 2008 Jun;112(11):2475-82. doi: 10.1002/cncr.23455.
PubMed 18428195
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Physical Activity Intervention to Manage Bowel Dysfunction in Rectal Cancer Survivors
- ClinicalTrials.gov ID
- NCT06435975
- Acronym / sponsor ID
- UPCC 20221
- Conditions
- Rectal Cancer, Rectosigmoid Cancer
- Keywords
- Rectal Cancer, Physical Activity, Bowel Dysfunction, Telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 6 Mar 2024 (actual)
- Study completion
- 6 Mar 2024 (actual)
- First posted
- 30 May 2024 (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.
The goal of this clinical trial is to test a telehealth-based personalized physical activity intervention in adult patients diagnosed with Stage I-III rectal cancer. The main question it aims to answer are how to better understand the experiences of rectal cancer survivors who are coping with bowel dysfunction and how physical activity can improve their quality of life.
Participants will be asked to:
- Complete surveys to assess bowel function and quality of life
- Participate in 12 Telehealth Sessions (one session a week) to discuss and review bowel dysfunction
- Perform daily physical activity
Detailed description
The goal of this clinical trial is to administer and determine the feasibility of a personalized physical activity intervention for rectal cancer survivors. Structured physical activity interventions will be administered over a three-month period. An exit interview will be conducted at the completion of this time period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Physical Activity, Other: Survey, Behavioral: Telehealth Lifestyle CoachingParticipants in this arm will be asked to complete a series of surveys, participate in telehealth-based interventions, and engage in moderate physical activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of Stage I-III cancers of the rectum/rectosigmoid.
- Age 18 or older
- Three months to 5 years post-treatment completion
- Have a rectal or anal anastomosis with a LARS score of 21-42
- At least 10 participants must be racial/ethnic minority (Black/African American, Hispanic/Latino)
Key exclusion criteria (1 listed)
- 1. Patients failing to meet all the above inclusion criteria will be excluded from 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 |
|---|---|---|
| Physical ActivityParticipants will perform a baseline +4000 steps/day for the duration of the study. Aerobic exercise, similar to a brisk walk, will be recommended as the primary mode of exercise. | Other | Experimental |
| SurveyParticipants will complete a series of survey at multiple points throughout this study to assess quality of life issues. Questionnaires may be completed via paper forms with prepaid postage envelopes or using a REDCap online survey. | Other | Experimental |
| Telehealth Lifestyle CoachingParticipants will meet with a health coach, the Principal Investigator, to review baseline bowel habits and symptoms as well as discuss physical activity and potential strategies to achieve this goal, on a weekly basis for 12 weeks. | Behavioural | Experimental |
Primary outcome
Feasibility of Physical Activity Intervention
Time frame: From enrollment to the end of treatment at 12 weeks.
Administer and determine the feasibility of a PA intervention. We will administer a telehealth physical activity intervention to 20 RC survivors (10 males and 10 females, at least 10 of which will be racial and/or ethnic minorities) over 12 weeks. Feasibility of the intervention will be measured by the percentage of participants who agree to participate of the total approached as well as completion of the intervention which will be defined as completion of ≥80% of the intervention (telehealth calls).
2 secondary outcomes
Acceptability and Participant Satisfaction with Physical Activity Intervention
Time frame: From enrollment to the end of treatment after 12 weeks.
Evaluation using Memorial Sloan Kettering Cancer Center Bowel Function Instrument Scale to describe the change in total bowel symptom score in the pilot cohort from minimum score of 13 to maximum score of 65, where the higher score is the better outcome.
Time frame: At 0 weeks, 3 weeks, and 6 months after completion of the initial intervention.
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 30 May 2024.
- Background: PubMed 16041212Hendren SK, O'Connor BI, Liu M, Asano T, Cohen Z, Swallow CJ, Macrae HM, Gryfe R, McLeod RS. Prevalence of male and female sexual dysfunction is high following surgery for rectal cancer. Ann Surg. 2005 Aug;242(2):212-23. doi: 10.1097/01.sla.0000171299.43954.ce.
- Background: PubMed 21135876Lange MM, van de Velde CJ. Urinary and sexual dysfunction after rectal cancer treatment. Nat Rev Urol. 2011 Jan;8(1):51-7. doi: 10.1038/nrurol.2010.206. Epub 2010 Dec 7.
- Background: PubMed 19540058Bruheim K, Guren MG, Skovlund E, Hjermstad MJ, Dahl O, Frykholm G, Carlsen E, Tveit KM. Late side effects and quality of life after radiotherapy for rectal cancer. Int J Radiat Oncol Biol Phys. 2010 Mar 15;76(4):1005-11. doi: 10.1016/j.ijrobp.2009.03.010. Epub 2009 Jun 18.
- Background: PubMed 20602501Hoerske C, Weber K, Goehl J, Hohenberger W, Merkel S. Long-term outcomes and quality of life after rectal carcinoma surgery. Br J Surg. 2010 Aug;97(8):1295-303. doi: 10.1002/bjs.7105.
- Background: PubMed 26159443Sun V, Grant M, Wendel CS, McMullen CK, Bulkley JE, Altschuler A, Ramirez M, Baldwin CM, Herrinton LJ, Hornbrook MC, Krouse RS. Dietary and Behavioral Adjustments to Manage Bowel Dysfunction After Surgery in Long-Term Colorectal Cancer Survivors. Ann Surg Oncol. 2015 Dec;22(13):4317-24. doi: 10.1245/s10434-015-4731-9. Epub 2015 Jul 10.
- Background: PubMed 28677077Krouse RS, Wendel CS, Garcia DO, Grant M, Temple LKF, Going SB, Hornbrook MC, Bulkley JE, McMullen CK, Herrinton LJ. Physical activity, bowel function, and quality of life among rectal cancer survivors. Qual Life Res. 2017 Nov;26(11):3131-3142. doi: 10.1007/s11136-017-1641-2. Epub 2017 Jul 4.
- Background: PubMed 22294757Fong DY, Ho JW, Hui BP, Lee AM, Macfarlane DJ, Leung SS, Cerin E, Chan WY, Leung IP, Lam SH, Taylor AJ, Cheng KK. Physical activity for cancer survivors: meta-analysis of randomised controlled trials. BMJ. 2012 Jan 30;344:e70. doi: 10.1136/bmj.e70.
- Background: PubMed 21464030Denlinger CS, Engstrom PF. Colorectal cancer survivorship: movement matters. Cancer Prev Res (Phila). 2011 Apr;4(4):502-11. doi: 10.1158/1940-6207.CAPR-11-0098.
- Background: PubMed 22539238Rock CL, Doyle C, Demark-Wahnefried W, Meyerhardt J, Courneya KS, Schwartz AL, Bandera EV, Hamilton KK, Grant B, McCullough M, Byers T, Gansler T. Nutrition and physical activity guidelines for cancer survivors. CA Cancer J Clin. 2012 Jul-Aug;62(4):243-74. doi: 10.3322/caac.21142. Epub 2012 Apr 26.
- Background: PubMed 21286822Grimmett C, Bridgewater J, Steptoe A, Wardle J. Lifestyle and quality of life in colorectal cancer survivors. Qual Life Res. 2011 Oct;20(8):1237-45. doi: 10.1007/s11136-011-9855-1. Epub 2011 Feb 1.
- Background: PubMed 24781887Brown JC, Schmitz KH. The prescription or proscription of exercise in colorectal cancer care. Med Sci Sports Exerc. 2014 Dec;46(12):2202-9. doi: 10.1249/MSS.0000000000000355.
- Background: PubMed 22237782Kushi LH, Doyle C, McCullough M, Rock CL, Demark-Wahnefried W, Bandera EV, Gapstur S, Patel AV, Andrews K, Gansler T; American Cancer Society 2010 Nutrition and Physical Activity Guidelines Advisory Committee. American Cancer Society Guidelines on nutrition and physical activity for cancer prevention: reducing the risk of cancer with healthy food choices and physical activity. CA Cancer J Clin. 2012 Jan-Feb;62(1):30-67. doi: 10.3322/caac.20140.
- American Cancer Society. Cancer Facts \& Figures 2020Link provided by the sponsor.
- 2018 Physical Activity Guidelines for Americans. US Department of Health and Human Services; 2008Link provided by the sponsor.
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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.
Erica Pettke, MD, MPH, FACS principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity, Survey and Telehealth Lifestyle Coaching in people with Rectal Cancer and Rectosigmoid Cancer, run by Abramson Cancer Center at Penn Medicine 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 9 inclusion and 1 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 May 2024. 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?
Feasibility of Physical Activity Intervention (time frame: From enrollment to the end of treatment at 12 weeks.). 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 NCT06435975, which also lists 26 linked publications.
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 May 2024.