Colonic NeoplasmsNCT01586416
Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients
A study testing Behavioral Intervention in people with Colonic Neoplasms, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to develop and pilot test a behavioral intervention for elderly adults in treatment for colon cancer, to enhance their skills for managing the challenges of completing chemotherapy regimens. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Colonic Neoplasms
- What is being tested?
- Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Dec 2020
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60 or older
- Verbal fluency in English
- Diagnosis of colon cancer
- Scheduled to initiate chemotherapy treatment for colon cancer
Who cannot join
- Active, unstable, untreated serious mental illness interfering with ability to participate
- Cognitive impairment interfering with ability to participate
- Receiving radiotherapy concomitant with chemotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The purpose of this study is to develop and pilot test a behavioral intervention for elderly adults in treatment for colon cancer, to enhance their skills for managing the challenges of completing chemotherapy regimens. The investigators will assess feasibility and acceptability of the intervention, and explore preliminary efficacy of the intervention for reducing psychological distress and improving rates of optimal chemotherapy adherence.
- Conditions
- Colonic Neoplasms
- Being tested
- Behavioral Intervention
- Keywords
- Colonic neoplasms, Older adults, Psychosocial Intervention, Chemotherapy adherence
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral InterventionBehavioural
Two or three one-hour sessions of an individual behavioral intervention led by a doctoral-level licensed psychologist during the first 12 weeks of chemotherapy. Intervention addresses modifiable behaviors for managing chemotherapy challenges.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Intervention | Experimental | Brief behavioral intervention on 2-3 sessions of tailored cognitive-behavioral therapy to support chemotherapy adherence and well-being of patients completing chemotherapy for colon cancer. Receives: Behavioral: Behavioral Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant satisfaction with intervention structure, timing and content
Participants rate acceptability of structure, timing and content of intervention using Likert-type response scales, and are also invited to provide brief qualitative feedback on opinions about intervention.
Measured: At approximately 12 weeks post-baseline
Number of participants who withdraw from study after enrollment
Measured: At approximately 12 weeks post-baseline
Secondary outcomes (3)
Change from baseline in the Hospital Anxiety and Depression Scale
Measured: At approximately 12 weeks post-baseline
Change from baseline in the Symptom Distress Scale
The 13-item Symptom Distress Scale (SDS)measures physical and psychological symptom-related distress.
Measured: At approximately 12 weeks post-baseline
Proportion of each chemotherapy component administered during the treatment regimen relative to the total planned amount
Measured: At approximately 24 weeks post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startDec 2012
- Primary completionSep 2014
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Lara Traeger, Massachusetts General Hospital
- Investigators
- Lara Traeger, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586416
- Sponsor's protocol ID
- 1R03CA157200-01A1
- Other IDs
- 1R03CA157200-01A1
- Status last verified
- Aug 2020
- First submitted
- 24 Apr 2012
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients
- ClinicalTrials.gov ID
- NCT01586416
- Acronym / sponsor ID
- 1R03CA157200-01A1
- Conditions
- Colonic Neoplasms
- Keywords
- Colonic neoplasms, Older adults, Psychosocial Intervention, Chemotherapy adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 26 Apr 2012 (estimated)
- 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 purpose of this study is to develop and pilot test a behavioral intervention for elderly adults in treatment for colon cancer, to enhance their skills for managing the challenges of completing chemotherapy regimens. The investigators will assess feasibility and acceptability of the intervention, and explore preliminary efficacy of the intervention for reducing psychological distress and improving rates of optimal chemotherapy adherence.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral Intervention | Experimental | Behavioral: Behavioral InterventionBrief behavioral intervention on 2-3 sessions of tailored cognitive-behavioral therapy to support chemotherapy adherence and well-being of patients completing chemotherapy for colon cancer. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 60 or older
- Verbal fluency in English
- Diagnosis of colon cancer
- Scheduled to initiate chemotherapy treatment for colon cancer
Key exclusion criteria (3 listed)
- Active, unstable, untreated serious mental illness interfering with ability to participate
- Cognitive impairment interfering with ability to participate
- Receiving radiotherapy concomitant with chemotherapy
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 |
|---|---|---|
| Behavioral InterventionTwo or three one-hour sessions of an individual behavioral intervention led by a doctoral-level licensed psychologist during the first 12 weeks of chemotherapy. Intervention addresses modifiable behaviors for managing chemotherapy challenges. | Behavioural | Behavioral Intervention |
Primary outcome
Participant satisfaction with intervention structure, timing and content
Time frame: At approximately 12 weeks post-baseline
Participants rate acceptability of structure, timing and content of intervention using Likert-type response scales, and are also invited to provide brief qualitative feedback on opinions about intervention.
Number of participants who withdraw from study after enrollment
Time frame: At approximately 12 weeks post-baseline
3 secondary outcomes
Change from baseline in the Hospital Anxiety and Depression Scale
Time frame: At approximately 12 weeks post-baseline
Change from baseline in the Symptom Distress Scale
Time frame: At approximately 12 weeks post-baseline
Proportion of each chemotherapy component administered during the treatment regimen relative to the total planned amount
Time frame: At approximately 24 weeks post-baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
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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.
Lara Traeger, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Intervention in people with Colonic Neoplasms, run by Massachusetts General Hospital 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 2 Sep 2020. 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?
Results are not available in the source record.
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?
Participant satisfaction with intervention structure, timing and content (time frame: At approximately 12 weeks post-baseline). 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?
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 2 Sep 2020.