Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Pathways is designed to help patients identify and pursue values-based goals and address potential goal obstacles, including lung cancer stigma.

Goal-setting intervention to help patients identify personal values, value-consistent goals, and ways to pursue goals and address goal obstacles. Although potential refinements may occur based on aim 1 (refining procedures and content with 6 patients), Pathways is designed to consist primarily of 2 in-person sessions (\~30-60 minutes) delivered when patients are in clinic for cancer treatment, with supporting phone calls and contact in between sessions.

Pathways

Laurie McLouth, PhD

The purpose of this research is to determine the feasibility of a new supportive intervention, called Pathways, for patients with advanced stage and metastatic lung cancer.

In this study, investigators will first test the Pathways procedures with 6 patients to identify any improvements that need to be made. Then, investigators will test the feasibility of the Pathways intervention with 20 patients who are undergoing cancer treatment for advanced stage or metastatic lung cancer. Pathways is designed to help patients set and pursue personal goals during lung cancer treatment. In this study, investigators want to see if they can recruit patients with lung cancer who are being treated at the University of Kentucky Markey Cancer Center to participate in the Pathways intervention.

Piloting Pathways With Lung Cancer Patients

Piloting Pathways, a Hope-enhancing Intervention to Address Activity and Role Function in Metastatic Lung Cancer Patients

Percentage of eligible and approached patients who agree to participate

Mean acceptability ratings on individual items of acceptability developed by study team (e.g., convenience of the intervention, helpfulness of the intervention, relevance of the intervention; scores of at least 7/10 on each item, possible range = 1-10, higher scores indicate higher acceptability).

Brief measure of satisfaction with ability and participation in activities and roles (e.g., work at home, regular personal and household responsibilities, do things for family) Higher scores indicate more satisfaction with participation. Raw scores range from 8 to 40. 8 items are responded to on a scale of 1 = not at all to 5 = very much.

Brief measure of agency and pathways thinking. 6 items responded to on a scale of 1 = definitely false to 8 = definitely true. Items are summed for a total score (possible range = 6 - 48). Higher scores indicate higher hope.

Brief measure assessing one's sense of purpose and that there are reasons for living; 4 items responded to on a scale of 1 = not at all to 5 = very much (possible raw score range = 4 - 20). Higher scores indicate greater meaning and purpose.

Brief measure assessing sense of worthlessness, helplessness, depression, etc. 6 items are responded to on a scale of 1 = never to 5 = always (possible raw scores range from 6-30). Higher scores indicate greater distress.

measure of lung cancer stigma. 25 items making up three subscales (perceived stigma, internalized stigma, and constrained disclosure). Items are responded to on a scale of 1 = not at all to 5 = extremely. Items are summed, with a higher score indicating greater lung cancer stigma/worse outcome (possible total score range = 25-125) . Clinical cutoff of a total score of 37.5 is suggested in literature as significant levels of stigma.

National Cancer Institute (NCI)

Laurie McLouth

Assistant Professor

Pathways is designed to help patients identify and pursue values-based goals and address potential goal obstacles, including lung cancer stigma.

Pathways: Goal-setting intervention to help patients identify personal values, value-consistent goals, and ways to pursue goals and address goal obstacles. Although potential refinements may occur based on aim 1 (refining procedures and content with 6 patients), Pathways is designed to consist primarily of 2 in-person sessions (\~30-60 minutes) delivered when patients are in clinic for cancer treatment, with supporting phone calls and contact in between sessions.

1 participant dropped from the study before baseline measures were collected.

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

53 participants were enrolled in the study; however, 1 participant dropped from the study before baseline measures were collected.

Dr. Laurie McLouth

98 potentially eligible people were approached, of whom 53 agreed to participate.

Feasibility of Enrollment: Percentage of Eligible and Approached Patients Who Agree to Participate

Convenience of intervention

Relevance of intervention

Helpfulness of intervention

1 participant skipped this measure so overall number is 39 instead of 40

Acceptability: Ratings

PROMIS Satisfaction With Participation in Social Roles - Short Form 8a

Hope - State Hope Scale (Snyder)

Purpose - PROMIS Meaning and Purpose 4a

Distress - PROMIS Depression Short Form 6a

Lung Cancer Stigma - Lung Cancer Stigma Inventory (Hamann)

Overall Study

Behaviors and Mental Disorders

Quality of Life

Pathways focuses on increasing patient hope to support personal goal pursuit during treatment for advanced lung cancer.

Enhanced Usual Care focuses on providing patients with education around common lung cancer concerns (e.g., pain and fatigue management) and resources to support them (e.g., supportive services available nationally and at the treating cancer center).

Delivered by a nurse or other healthcare provider, includes 2 in-person sessions, and phone check-ins, and occurs primarily during infusion visits. Includes a Pathways Toolkit with handouts on values and goal setting, as well as resources on symptom management, lung cancer stigma, communication strategies, and other cancer center resources.

Pathways Toolkit handouts on symptom management, lung cancer stigma, communication strategies, and other cancer center resources provided to participants. The Toolkit will be reviewed with patients in person to orient them to its purpose and contents.

Enhanced Usual Care

This study will compare the effects of a brief supportive intervention, called Pathways, against enhanced usual care on the mental health and quality of life of people undergoing treatment for advanced lung cancer. Patients will complete baseline survey measures and be randomized to intervention. Survey measures will be collected again mid-intervention, post-intervention and at 6- and 12-week follow-up, with analyses focused on changes pre- to post-intervention.

Pathways, a Hope Intervention to Support Personal Goal Pursuit, Mental Health, and Quality of Life During Advanced Lung Cancer Treatment

Pathways, a Hope-Based Intervention to Support Personal Goal Pursuit, Mental Health, and Quality of Life During Treatment for Advanced Lung Cancer

Data Description: The proposed research will include clinical and patient-reported outcome data from approximately 234 participants with advanced stage lung cancer. Patients will complete surveys prior to randomization, mid-intervention period, post-intervention, and at follow-ups. In addition to these survey data, disease and medical treatment information will be abstracted from the electronic health record, including cancer treatments received, performance status, hospitalizations, and death.

Data Archive: Data from this study will be submitted to ICPSR (Inter-university Consortium for Political and Social Research), which will make de-identified data available as described under "access criteria."

Depression symptoms will be measured using the PROMIS Depression Short Form 6a: 6 items are responded to on a scale of 1 = never to 5 = always. Raw scores range from 6 to 30.

Higher scores indicate more depression.

Hope will be measured using Snyder's State Hope Scale. 6 items responded to on a scale of 1 = definitely false to 8 = definitely true. Raw scores range from 6 to 48. Items are summed for a total score. Higher scores indicate higher hope.

Anxiety symptoms are measured using the PROMIS Anxiety Short Form 4a. 4 items are responded to on a scale of 1 = never to 5 = always. Raw scores range from 4 to 20. Higher scores indicate more anxiety.

Demoralization symptoms are measured using the Demoralization Scale II: 16 items are responded to on a scale of 0 = never to 2 = always; Raw scores range from 0-32. Higher scores indicate more demoralization.

Positive affect is measured using the PROMIS 15a positive affect form. Higher scores indicate more positive affect. Items are responded to on a scale of 1 = never to 5 = always. Raw scores range from 15 to 45. Higher scores indicate more positive affect.

Meaning/Peace is measured using the FACIT-Spiritual Well-being Meaning/Peace Subscale. 8 items are responded to on a scale of 0 = not at all to 4 = very much. Raw scores range from 0-32. Higher scores indicate more meaning/peace.

Quality of Life is measured using the FACT-G7. 7 items are responded to on a scale of 0 = not at all to 4 = very much to assess physical, emotional, and functional wellbeing. Raw scores range from 0 to 28. Higher scores indicate better quality of life.

Satisfaction with Social Activities and Roles is measured using the ROMIS Satisfaction with Participation in Social Roles 8a Short Form. 8 items are responded to on a scale of 1 = not at all to 5 = very much. Raw scores range from 8 to 40. Higher scores indicate better function.

Digestive System Diseases

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Participants assigned to the PATHWAYS Intervention will receive: 1) four coaching sessions, 2) a comprehensive patient education guidebook, and 3) a coaching session workbook.

Participants assigned to the enhanced usual care will receive: 1) an information resource guide for navigating information online.

The PATHWAYS intervention is a psychoeducational intervention comprised of three components.

PATHWAYS

The enhanced usual care condition consists of an information resource guide.

Enhanced usual care

Kelsey Lau-Min, MD, MSCE

The aim of this study is to evaluate the efficacy of a brief psychoeducational intervention to improve the self-efficacy of patients with locally advanced rectal cancer who are initiating multimodality treatment (e.g., total neoadjuvant therapy).

This is a randomized control trial that will be split into two phases. Study Phase I will test 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 who are initiating multimodality treatment. It is expected that this phase will enroll 20 participants. Study Phase II will test the efficacy of the psychoeducational intervention after it has been refined using findings from Study Phase I. It is expected this phase will enroll 100 participants.

In this study, participants will complete survey questions and will be randomly assigned to either receive the intervention (consisting of 4 coaching sessions with a study clinician, a comprehensive patient education guidebook, and a coaching session workbook) or enhanced usual care (consisting of an information resource guide for navigating information online).

It is expected that about 120 people will take part in this research study.

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).

An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer

PATHWAYS: An Informational and Supportive Care Intervention to Enhance Self-Efficacy for Patients With Locally Advanced Rectal Cancer

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.

The primary outcome for Study Phase I will be feasibility, defined as ≥60% retention of participants over the four-week intervention.

The primary outcome for Study Phase II will be self-efficacy, assessed using the Communication and Attitudinal Self-Efficacy Scale for Cancer (CASE-Cancer). CASE-Cancer scores range from 12-48, with higher scores indicating greater self-efficacy.

The secondary outcome for Study Phase II will be acceptability of the intervention, defined as ≥80% of participants reporting Client Satisfaction Questionnaire (CSQ-8) scores of ≥20 (scale from 8-32, higher scores indicate higher satisfaction).

A secondary outcome for Study Phase II will be a different measure of self-efficacy, assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy Measures for Managing Chronic Conditions. PROMIS scores range from 8-40, with higher scores indicating greater self-efficacy.

A secondary outcome for Study Phase II will be coping, assessed using the Brief Cope (B-COPE). B-COPE scores range from 28-112, with higher scores indicating greater coping ability.

A secondary outcome for Study Phase II will be resilience, assessed using the Brief Resilience Scale (BRS). BRS scores range from 6-30, with higher scores indicating greater resilience.

A secondary outcome for Study Phase II will be social isolation, assessed using the Patient-Reported Outcomes Measurement Information System Social Isolation (PROMIS SI). PROMIS SI scores range from 4-20, with higher scores indicating greater social isolation.

A secondary outcome for Study Phase II will be decisional regret, assessed using the Decision Regret Scale (DRS). DRS scores range from 5-25, with higher scores indicating greater decisional regret.

Assessed using the Edmonton Symptom Assessment Scale (ESAS). ESAS scores range from 0-90, with higher scores indicating greater symptom burden.

A secondary outcome for Study Phase II will be psychological distress, assessed using the Patient Health Questionnaire (PHQ-4). ESAS scores range from 0-12, with higher scores indicating greater psychological distress.

A secondary outcome for Study Phase II will be quality of life, assessed using the Functional Assessment of Cancer Therapy-Colorectal (FACT-C). FACT-C scores range from 0-136, with higher scores indicating greater quality of life.

Massachusetts General Hospital

Principal Investigator

Carcinoma

Colonic Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Anesthetics, Local

The exercise regime consists of 10 sessions of exercise against a constant load, each lasting 60 seconds, separated by 60 seconds of recovery eliciting 90% maximal heart rate. The 6 sessions are held over a 2 week period.

Exercise programme

muscle biopsy under local anaesthetic taken from the thigh, again for analysis and storage 3 times: before, during and after the exercise programme

Muscle biopsy

Tamas Hickish, FRCP

This pilot study looks to explore the biological effects of exercise on cancer and muscle cells using a two week exercise program (HIThigh intensity training) on 20 patients with newly diagnosed and operable colorectal cancer following diagnosis and prior to surgery. Maximal oxygen uptake will also be measured. The aim of this pilot is to assess the feasibility of recruiting participants to and carrying out a two week preoperative exercise program in patients with colorectal cancer.

Patients undergoing investigation for symptoms of colorectal cancer presenting to the hospital will undergo standard diagnostic procedures. Once resectable nonmetastatic cancer has been diagnosed (i.e. cancer that has not spread beyond the bowel), is amenable to surgical resection as decided by the colorectal multidisciplinary and if the patient fulfills the selection criteria, they will be asked if they wish to participate in the study. They will be given information regarding the study at the time of diagnosis. If they give their consent then a formal consenting process will take place at the next routine appointment.

During this appointment the patient will have the opportunity to ask questions. A member of the study team will explain the study in detail, answer any questions potential participants (and their partners/ carers) have. The patient is free to refuse participation or withdraw from the study at any time without this affecting their care, this is explained in the information and will be discussed further at the time of informed consent. If the patient agrees to participate in the trial, following the provision of informed consent and before embarking on the exercise programme they will need to fill in two questionnaires, the International Physical Activity Questionnaire (Long) and Dietary Intervention in Primary Care Questionnaire (DINE). They will be counseled to try and maintain their normal exercise level and their calorie intake. Blood samples will also be taken, analyzed and stored for further analysis including possible genetic analysis at a later stage before starting the exercise regime. They will have a muscle biopsy under local anaesthetic taken from the thigh, again for analysis and storage.

Participants will undergo an initial assessment of their baseline exercise ability and oxygen absorption using an upright exercise bike with concurrent ECG readings and breath analysis. The two week preoperative exercise regime will be planned depending on the patient's operation date. The exercise regime consists of 10 sessions of exercise against a constant load, each lasting 60s, separated by 60s of recovery eliciting 90% maximal heart rate.

The 6 sessions are held over a 2 week period. Each patients exercise ability and oxygen absorption will be remeasured at the end of the 2 week period and a second sample of blood taken for comparison. During the operation a sample of adipose tissue near the tumour site will be taken separately to the main sample. A muscle biopsy from the thigh will also be taken at the same time. As a standard of clinical care all patients are reviewed in the outpatient setting 6 weeks postoperatively. When patients attend this follow up appointment a final blood test and muscle biopsy (under local anaesthetic) will be taken to assess the longer term effects of the exercise program. Patient consent will be sought for this separately although it will be discussed at the initial introduction to the study.

Patients are free to withdraw from the study at any time and if there are any adverse events or concerns regarding the continuation of the study for a patient then they will be withdrawn.

EDICT - Exercise inDuced Changes In Colorectal Cancer Tissues

Clinical and Biological Effects of a Preoperative Exercise Programme in Colorectal Tumour and Skeletal Muscle Tissues (Exercise inDuced Changes In Colorectal Cancer Tissues)

To assess the feasibility of carrying out a two week preoperative exercise program in patients with colorectal cancer and to assess the effects of preoperative exercise on the proliferation of colorectal cancer cells by measuring the change in the percentage of cells staining positive for Ki67 (a measure of cell proliferation).

Measuring changes in molecular markers for the effects of exercise and/or diet on AMPK/mTOR signalling pathway (phosphorylated 4EBP1 (P4EBP1), phosphorylated protein kinase B (PPKB/AKT), and phosphorylated AMPK (PAMPK).

Measuring changes in AKT expression normal colonic tissue - Intensity of AKT1/AKT2 staining, or AKT phosphorylation, a marker of insulin receptor signalling in cells.

Assessing Apoptosis index - Percentage of tumour cells staining positive for DNA fragmentation, a marker of cells undergoing apoptosis and therefore cell death.

Measuring changes in molecular markers that may mediate or modify exercise/dietary effects in tumour tissues (IR, IGF1R, p53 and its transcriptional target p21, ER, progesterone receptor, tumor necrosis factor-alpha converting enzyme and TIMP3).

Assessing gene expression profiles focusing on gene associated with insulin resistance.

Assessing the 11 gene signature that help to predict maximal oxygen uptake gain in patients before and after exercise

Cortisol levels to evaluate levels of biological stress.

Postoperative complications up to 30 days postoperatively

Moderator variables including state of motivational readiness for exercise, weight change, depression and anxiety

The Royal Bournemouth Hospital

Laurent Calvel, MD, PhD

Saïd CHAYER, PhD, HDR

Colin VERCUEIL, MD

In view to develop a study design for a study that would analyze the pathways of palliative care prospectively, this work will identify the individual factors that would be significantly associated with typical pathways of palliative care.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Piloting Pathways With Lung Cancer Patients	NCT04161157	Metastatic Lung...	Pathways	18 Years -	University of Kentucky
Pathways, a Hope Intervention to Support Personal Goal Pursuit, Mental Health, and Quality of Life During Advanced Lung Cancer Treatment	NCT06047301	Lung Cancer	Pathways Enhanced Usual ...	18 Years -	University of Kentucky
Piloting Pathways With Lung Cancer Patients	NCT04161157	Metastatic Lung...	Pathways	18 Years -	University of Kentucky
An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer	NCT05914766	Rectal Cancer Self Efficacy	PATHWAYS Enhanced usual ...	18 Years -	Massachusetts General Hospital
Pathways, a Hope Intervention to Support Personal Goal Pursuit, Mental Health, and Quality of Life During Advanced Lung Cancer Treatment	NCT06047301	Lung Cancer	Pathways Enhanced Usual ...	18 Years -	University of Kentucky
Pathways, a Hope Intervention to Support Personal Goal Pursuit, Mental Health, and Quality of Life During Advanced Lung Cancer Treatment	NCT06047301	Lung Cancer	Pathways Enhanced Usual ...	18 Years -	University of Kentucky
EDICT - Exercise inDuced Changes In Colorectal Cancer Tissues	NCT02056691	Colorectal Canc...	Exercise progra... Muscle biopsy	18 Years -	The Royal Bournemouth Hospital
Pathways of Patients Followed in Palliative Care at the University Hospital of Strasbourg: a Retrospective Pilot Study	NCT04961203	Cancer		18 Years -	University Hospital, Strasbourg, France

Spots Global Cancer Trial Database for pathways

Every month we try and update this database with for pathways cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pathways

Every month we try and update this database with for pathways cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pathways cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.