Rectal CancerPATHWAYSNCT05914766
An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer
A study testing PATHWAYS in people with Rectal Cancer and Self Efficacy, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The aim of this study is to evaluate the feasibility and acceptability of conducting a randomized trial of a brief psychoeducational intervention versus enhanced usual care for patients with locally advanced rectal cancer who are initiating neoadjuvant multimodality treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Self Efficacy
- What is being tested?
- PATHWAYS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Sep 2023to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age≥18 years
- Within 8 weeks after documented decision to pursue multi-modality therapy for newly diagnosed LARC (i.e., stage II or III disease)
- Able to complete study procedures English or with the assistance of an interpreter
Who cannot join
- Comorbid health condition that would interfere with study participation, as identified by cancer care team
- Has undergone treatment for a prior colorectal cancer
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Kelsey Lau-Min, MD, MSCE, 617-724-4000, klau-min@mgh.harvard.edu
Kelsey Lau-Min, MD, MSCE
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Christo Manz, MD, MSHP, 617-632-3315, christopher_manz@dfci.harvard.edu
Christopher Manz, MD, MSHP
About this study
Official title: PATHWAYS: An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer
The aim of this study is to evaluate the feasibility and acceptability of conducting a randomized trial of a brief psychoeducational intervention versus enhanced usual care for patients with locally advanced rectal cancer who are initiating neoadjuvant multimodality treatment.
Read the detailed description
This is a randomized controlled trial that is split into two phases. Study Phase I tested the feasibility and acceptability of a study evaluating a psychoeducational intervention relative to a control condition for improving self-efficacy in patients with locally advanced rectal cancer initiating multimodality treatment. This phase enrolled 20 participants.
Study Part 2 was initially planned as an adequately powered RCT to evaluate intervention efficacy for enhancing patient self-efficacy for managing treatment-related challenges and maintaining quality of life. Due to the substantial refinements that were made to the PATHWAYS intervention and study procedures after Study Part 1, we have elected to change Study Part 2 to a second pilot randomized controlled trial to evaluate the feasibility and acceptability of the refined PATHWAYS study among a larger group of patients (n=60).
Participants in the intervention arm will be invited to receive the PATHWAYS intervention, including 4 coaching sessions with a study clinician focused on information and support related to multimodality treatment for LARC. Participants in the control arm will receive an information resource guide that is tailored for patients with LARC.
It is expected that about 80 people will take part in this research study.
- Conditions
- Rectal Cancer, Self Efficacy
- Being tested
- PATHWAYS, Enhanced usual care
- Keywords
- total neoadjuvant therapy, locally advanced rectal cancer, self efficacy, psychoeducational, multimodality treatment
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PATHWAYSBehavioural
The PATHWAYS intervention is a psychoeducational intervention comprised of four behavioral coaching sessions and a patient education guidebook.
Enhanced usual careOther
The enhanced usual care condition consists of an information resource guide.
| Study group | Role | What they receive |
|---|---|---|
| Study Phase I: PATHWAYS Intervention | Experimental | Participants assigned to the PATHWAYS Intervention will receive: 1) four coaching sessions, 2) a comprehensive patient education guidebook, and 3) a coaching session workbook. Receives: Behavioral: PATHWAYS |
| Study Phase I: Enhanced Usual Care | Active comparator | Participants assigned to the enhanced usual care will receive: 1) an information resource guide for navigating information online. Receives: Other: Enhanced usual care |
| Study Phase II: PATHWAYS Intervention | Experimental | Participants assigned to the PATHWAYS Intervention will receive: 1) four coaching sessions and 2) a comprehensive patient education guidebook. The intervention has been modified and refined based on feedback from Study Phase I. Receives: Behavioral: PATHWAYS |
| Study Phase II: Enhanced Usual Care | Active comparator | Participants assigned to the enhanced usual care will receive: 1) an information resource guide for navigating information online. Receives: Other: Enhanced usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants retained in the intervention (feasibility)
The primary outcome will be feasibility, defined as ≥60% retention of participants over the four-week intervention.
Measured: 4 weeks
Secondary outcomes (2)
Proportion of patients enrolled on the study (feasibility)
A secondary feasibility outcome will be defined as ≥60% enrollment among all eligible patients
Measured: 12 weeks
Proportion of participants reporting acceptability of the intervention (acceptability)
A secondary outcome of acceptability will be defined as ≥80% of participants in the intervention arm reporting Client Satisfaction Questionnaire (CSQ-8) scores of ≥20 (scale from 8-32, higher scores indicate higher satisfaction).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start21 Sep 2023
- Primary completion21 May 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either the intervention or enhanced usual care. Randomization will be stratified by treatment sequence (e.g., chemotherapy first vs. concurrent chemoradiation first).
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelsey S. Lau-Min, MD, Massachusetts General Hospital
- Investigators
- Kelsey Lau-Min, MD, MSCE, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914766
- Sponsor's protocol ID
- 23-115
- Acronym
- PATHWAYS
- Status last verified
- Oct 2026
- First submitted
- 13 Jun 2023
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PATHWAYS: An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT05914766
- Acronym / sponsor ID
- PATHWAYS / 23-115
- Conditions
- Rectal Cancer, Self Efficacy
- Keywords
- total neoadjuvant therapy, locally advanced rectal cancer, self efficacy, psychoeducational, multimodality treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 21 May 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 22 Jun 2023 (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 aim of this study is to evaluate the feasibility and acceptability of conducting a randomized trial of a brief psychoeducational intervention versus enhanced usual care for patients with locally advanced rectal cancer who are initiating neoadjuvant multimodality treatment.
Detailed description
This is a randomized controlled trial that is split into two phases. Study Phase I tested the feasibility and acceptability of a study evaluating a psychoeducational intervention relative to a control condition for improving self-efficacy in patients with locally advanced rectal cancer initiating multimodality treatment. This phase enrolled 20 participants.
Study Part 2 was initially planned as an adequately powered RCT to evaluate intervention efficacy for enhancing patient self-efficacy for managing treatment-related challenges and maintaining quality of life. Due to the substantial refinements that were made to the PATHWAYS intervention and study procedures after Study Part 1, we have elected to change Study Part 2 to a second pilot randomized controlled trial to evaluate the feasibility and acceptability of the refined PATHWAYS study among a larger group of patients (n=60).
Participants in the intervention arm will be invited to receive the PATHWAYS intervention, including 4 coaching sessions with a study clinician focused on information and support related to multimodality treatment for LARC. Participants in the control arm will receive an information resource guide that is tailored for patients with LARC.
It is expected that about 80 people will take part in this research study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be randomized to either the intervention or enhanced usual care. Randomization will be stratified by treatment sequence (e.g., chemotherapy first vs. concurrent chemoradiation first).
| Arm | Type | Receives |
|---|---|---|
| Study Phase I: PATHWAYS Intervention | Experimental | Behavioral: PATHWAYSParticipants assigned to the PATHWAYS Intervention will receive: 1) four coaching sessions, 2) a comprehensive patient education guidebook, and 3) a coaching session workbook. |
| Study Phase I: Enhanced Usual Care | Active comparator | Other: Enhanced usual careParticipants assigned to the enhanced usual care will receive: 1) an information resource guide for navigating information online. |
| Study Phase II: PATHWAYS Intervention | Experimental | Behavioral: PATHWAYSParticipants assigned to the PATHWAYS Intervention will receive: 1) four coaching sessions and 2) a comprehensive patient education guidebook. The intervention has been modified and refined based on feedback from Study Phase I. |
| Study Phase II: Enhanced Usual Care | Active comparator | Other: Enhanced usual careParticipants assigned to the enhanced usual care will receive: 1) an information resource guide for navigating information online. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age≥18 years
- Within 8 weeks after documented decision to pursue multi-modality therapy for newly diagnosed LARC (i.e., stage II or III disease)
- Able to complete study procedures English or with the assistance of an interpreter
Key exclusion criteria (2 listed)
- Comorbid health condition that would interfere with study participation, as identified by cancer care team
- Has undergone treatment for a prior colorectal cancer
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 |
|---|---|---|
| PATHWAYSThe PATHWAYS intervention is a psychoeducational intervention comprised of four behavioral coaching sessions and a patient education guidebook. | Behavioural | Study Phase I: PATHWAYS Intervention, Study Phase II: PATHWAYS Intervention |
| Enhanced usual careThe enhanced usual care condition consists of an information resource guide. | Other | Study Phase I: Enhanced Usual Care, Study Phase II: Enhanced Usual Care |
Primary outcome
Proportion of participants retained in the intervention (feasibility)
Time frame: 4 weeks
The primary outcome will be feasibility, defined as ≥60% retention of participants over the four-week intervention.
2 secondary outcomes
Proportion of patients enrolled on the study (feasibility)
Time frame: 12 weeks
Proportion of participants reporting acceptability of the intervention (acceptability)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Kelsey Lau-Min, MD, MSCE principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PATHWAYS in people with Rectal Cancer and Self Efficacy, run by Massachusetts General Hospital 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 3 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: looking for participants now, as of the sponsor's last update on 9 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelsey Lau-Min, MD, MSCE (617-724-4000, klau-min@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants retained in the intervention (feasibility) (time frame: 4 weeks). 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 9 Oct 2026.