Advanced Solid Tumor DiseasesNCT01323309
Trial of Individual Psychosocial Interventions for Cancer Patients
An observational study of Advanced Solid Tumor Diseases, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The aim of the study is to compare the benefits of three types of individual treatment programs for cancer patients: Meaning-Centered counseling, Supportive counseling, and Enhanced Usual Care. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Advanced Solid Tumor Diseases
- What is being tested?
- Individual Meaning-Centered Psychotherapy (IMCP) and standard Individual Supportive Psychotherapy (ISP)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 346 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2011to 22 Feb 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Potential candidates for the study who meet the eligibility criteria of cancer diagnosis and stage will be identified by the research staff and/or participating oncology staff or co-investigators. Study investigators in the Pain \& Palliative Care Service the Breast Cancer Medicine Service, the Head \& Neck Oncology Service, the Thoracic Medicine Service, the Gastrointestinal Oncology Service, and the Genito-Urinary Oncology Service will serve as liaisons to the Research Staff and help screen and identify potential subjects for the study.
Who may be able to join
- 21 years of age and older
- Able to communicate and understand English well enough to complete assessments and intervention**
- Patients solid tumors with advanced disease receiving ambulatory care at MSKCC*.
- Distress Thermometer rating of 4 or greater*
- Patients who do not meet these eligibility criteria may be offered participation as a training case (See inclusion criteria for Training Cases below).
- Subject Inclusion Criteria- Training Cases
Show all 11Show fewer
- 21 years of age and older
- Able to communicate and understand English well enough to complete the intervention**
- Patients with solid tumors with advanced disease receiving ambulatory care at MSKCC with a Distress Thermometer rating of 3 or less. or Patients with solid tumors who do not meet eligibility criteria for advanced disease receiving ambulatory care at MSKCC.
- or Patients solid tumors with advanced disease receiving ambulatory care at MSKCC who have participated in a prior meaning focused intervention study. or Patients with solid tumors with advanced disease receiving ambulatory care at MSKCC who have enrolled in this study, been assigned to the EUC arm, and completed all study requirements including follow-up assessments.
- The study treatment manual materials and assessments were designed and validated in English and are not currently available in other languages. Translation of the intervention and questionnaires into other languages would require reestablishing the reliability and validity of them. Therefore, participants must be able to communicate in English.
Who cannot join
- In the judgment of the treating physician and/or the consenting professional, presence of significant cognitive impairment (i.e., delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection.
- Baseline Karnofsky Performance Rating Scale (KPRS) score below 60 or physical limitations sufficient to preclude participation in a 7 session outpatient psychotherapy intervention.
- In the judgment of the consenting professional, severe psychiatric disturbance sufficient that would preclude participation in the intervention (patients whose psychiatric disorder is well controlled on medication will be eligible).
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Randomized Controlled Trial of Individual Psychosocial Interventions for Cancer Patients
The aim of the study is to compare the benefits of three types of individual treatment programs for cancer patients: Meaning-Centered counseling, Supportive counseling, and Enhanced Usual Care.
We would like to train therapists in administering these types of counseling, so that they have expertise to work on the study. The therapists will administer either the Meaning-Centered counseling or the Supportive counseling, as part of their training.
Many cancer patients use counseling or other resources to help with the emotional burden of their illnesses. Counseling often helps them cope with cancer by giving them a place to express their feelings. "Meaning-Centered" counseling aims to teach cancer patients how to maintain or even increase a sense of meaning and purpose in their lives, despite cancer. "Supportive" counseling is intended to help the patient cope with cancer by giving them a place to express their feelings and get support. Enhanced Usual Care is intended to offer the patient referrals and resources that are matched to their individual needs in addition to the care they are already receiving at MSKCC.
- Conditions
- Advanced Solid Tumor Diseases
- Being tested
- Individual Meaning-Centered Psychotherapy (IMCP), standard Individual Supportive Psychotherapy (ISP), enhanced usual care (EUC)
- Keywords
- Supportive Psychotherapy, Therapy, 11-021
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual Meaning-Centered Psychotherapy (IMCP)Behavioural
IMCP is based on the principles of Viktor Frankl's Logotherapy, and is designed to help patients with advanced cancer sustain or enhance a sense of meaning, peace and purpose in their lives even as they approach the end of life. IMCP is structured as a 7-session (1-hour weekly sessions) individual intervention that utilizes a mixture of didactics, discussion and experiential exercises that focus around particular themes related to meaning and advanced cancer. In addition we will be asking patients in the IMCP arm to complete an optional weekly session rating survey
standard Individual Supportive Psychotherapy (ISP)Behavioural
The ISP intervention utilized as the comparison treatment condition in this study, is adapted from the Supportive Group Psychotherapy manualized intervention developed by David Payne (1997) and adapted by Drs. Kissane, Breitbart and colleagues into the ISP manualized intervention. This intervention is a 7-session individual supportive psychotherapy utilizing an approach to supportive psychotherapy based on models described by Rogers. The essential components of supportive psychotherapy are integrated into this manualized intervention, including: reassurance, explanation, guidance, suggestion, encouragement, affecting changes in patient's environment, and permission for catharsis.
enhanced usual care (EUC)Behavioural
Also called Several referrals may be made based on identified problem areas, using the following guidelines:, • "Practical Problems" - Social Work on their disease management team, • "Family Problems"- Family Clinic at MSKCC Counseling Center, • "Emotional Problems" - MSKCC Counseling Center
We are therefore including what we refer to as an "enhanced" usual care arm to this randomized controlled trial to address the ethical issues raised by utilizing a usual care condition in a vulnerable advanced cancer population. Participants will receive feedback about their level of distress (based on the DT administered at screening) and given appropriate targeted referrals based on levels of distress and problem areas endorsed. Participants will be given a letter with a list of appropriate referrals.
| Study group | Role | What they receive |
|---|---|---|
| Individual Meaning-Centered Psychotherapy (IMCP) | Not described Receives: Behavioral: Individual Meaning-Centered Psychotherapy (IMCP) | |
| standard Individual Supportive Psychotherapy (ISP) | Not described Receives: Behavioral: standard Individual Supportive Psychotherapy (ISP) | |
| enhanced usual care (EUC) | Not described Receives: Behavioral: enhanced usual care (EUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R)
The Life Attitude Profile-Revised (LAP-R) is a 48-item self-report measure of discovered meaning and purpose in life and the motivation to find meaning and purpose in life. There are 6 subscales: Purpose (8 items, Minimum 8, Maximum 56, Higher is better), Coherence (8 items, Minimum 8, Maximum 56, Higher is better), Life control (8 items, Minimum 8, Maximum 56, Higher is better), Death acceptance (8 items, Minimum 8, Maximum 56, Higher is better), Existential transcendence (16 items, Minimum 16, Maximum 112, Higher is better), Personal Meaning (16 items, Minimum 16, Maximum 112, Higher is better), Goal Seeking (8 items, Minimum 8, Maximum 56, Higher is better): LAP-R total score (48 items, Minimum 72, Maximum 504, Higher is better). The LAP-R total score is derived by summing all subscales.
Measured: baseline meaning making measures and again at post-intervention (approximately week 8)
Secondary outcomes (3)
Clinical and Demographic Variables That May Correspond to Differential Responses to Individual Meaning-Centered Psychotherapy
The Functional Assessment of Chronic Illness Therapy Spiritual Well-Being Scale (SWB) comprises 12 items, each on a 0 ('Not at All') to 4 ('Very Much'). The SWB total score is derived by summing the responses, with a higher score representing high spiritual well-being. The minimum score is 0 and the maximum score is 48.
Measured: baseline meaning making measures and again at post-intervention (approximately week 8)
The Relative Impact of Individual Meaning-Centered Psychotherapy on Different Aspects of Meaning (e.g., Purpose, Coherence, Existential Vacuum), as Well as on Different Aspects of Spiritual Well-being (Meaning Versus Faith),
Single Item Scale (SIS) from the McGill Quality of Life Questionnaire (MQOL): The McGill Quality Of Life Questionnaire is a 17-item scale, with each item rated on a scale of 0 to 10, divided into four domains (the Single-Item Scale (SIS), physical symptoms, feelings and thoughts, and social). It is a brief, self-report instrument designed to assess various domains of psychological, spiritual, and physical functioning among terminally ill patients. In this study the SIS from the MQOL was used. For each scale participants rate their current functioning on a scale of 0 to 10, 0 being Very Bad and 10 being Excellent, higher is better.
Measured: baseline meaning making measures and again at post-intervention (approximately week 8)
Whether an Enhanced Sense of Meaning "Explains" (Mediates) Improved Psychological Well-being (i.e., Increased Quality of Life, Decreased Psychological Distress).
The Schedule of Attitudes towards Hastened Death (SAHD) comprises 20 TRUE/FALSE questions on the presence or absence of attitudes towards hastened death. A scale score is derived by tallying the number of items endorsed. The minimum score is 0 (better, no thoughts on hastened death) and the maxim score is 20 (worst, many thoughts on hastened death).
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study start22 Mar 2011
- Primary completion22 Feb 2023
- Study completion22 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid Tumor DiseasesStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Fordham University
- Responsible party
- Sponsor
- Investigators
- William Breitbart, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01323309
- Sponsor's protocol ID
- 11-021
- Status last verified
- Feb 2023
- First submitted
- 24 Mar 2011
- Last updated
- 1 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Marziliano A, Applebaum A, Moyer A, Pessin H, Rosenfeld B, Breitbart W. The Impact of Matching to Psychotherapy Preference on Engagement in a Randomized Controlled Trial for Patients With Advanced Cancer. Front Psychol. 2021 Feb 24;12:637519. doi: 10.3389/fpsyg.2021.637519. eCollection 2021.
PubMed 33732196
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Individual Psychosocial Interventions for Cancer Patients
- ClinicalTrials.gov ID
- NCT01323309
- Acronym / sponsor ID
- 11-021
- Conditions
- Advanced Solid Tumor Diseases
- Keywords
- Supportive Psychotherapy, Therapy, 11-021
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Fordham University
- Study start
- 22 Mar 2011 (actual)
- Primary completion
- 22 Feb 2023 (actual)
- Study completion
- 22 Feb 2023 (actual)
- First posted
- 25 Mar 2011 (estimated)
- Results
- Posted 1 Jul 2024
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 the study is to compare the benefits of three types of individual treatment programs for cancer patients: Meaning-Centered counseling, Supportive counseling, and Enhanced Usual Care.
We would like to train therapists in administering these types of counseling, so that they have expertise to work on the study. The therapists will administer either the Meaning-Centered counseling or the Supportive counseling, as part of their training.
Many cancer patients use counseling or other resources to help with the emotional burden of their illnesses. Counseling often helps them cope with cancer by giving them a place to express their feelings. "Meaning-Centered" counseling aims to teach cancer patients how to maintain or even increase a sense of meaning and purpose in their lives, despite cancer. "Supportive" counseling is intended to help the patient cope with cancer by giving them a place to express their feelings and get support. Enhanced Usual Care is intended to offer the patient referrals and resources that are matched to their individual needs in addition to the care they are already receiving at MSKCC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individual Meaning-Centered Psychotherapy (IMCP) | – | Behavioral: Individual Meaning-Centered Psychotherapy (IMCP) |
| standard Individual Supportive Psychotherapy (ISP) | – | Behavioral: standard Individual Supportive Psychotherapy (ISP) |
| enhanced usual care (EUC) | – | Behavioral: enhanced usual care (EUC) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential candidates for the study who meet the eligibility criteria of cancer diagnosis and stage will be identified by the research staff and/or participating oncology staff or co-investigators. Study investigators in the Pain \& Palliative Care Service the Breast Cancer Medicine Service, the Head \& Neck Oncology Service, the Thoracic Medicine Service, the Gastrointestinal Oncology Service, and the Genito-Urinary Oncology Service will serve as liaisons to the Research Staff and help screen and identify potential subjects for the study.
Key inclusion criteria (11 listed)
- 21 years of age and older
- Able to communicate and understand English well enough to complete assessments and intervention**
- Patients solid tumors with advanced disease receiving ambulatory care at MSKCC*.
- Distress Thermometer rating of 4 or greater*
- Subject Inclusion Criteria- Training Cases
Key exclusion criteria (3 listed)
- In the judgment of the treating physician and/or the consenting professional, presence of significant cognitive impairment (i.e., delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection.
- Baseline Karnofsky Performance Rating Scale (KPRS) score below 60 or physical limitations sufficient to preclude participation in a 7 session outpatient psychotherapy intervention.
- In the judgment of the consenting professional, severe psychiatric disturbance sufficient that would preclude participation in the intervention (patients whose psychiatric disorder is well controlled on medication will be eligible).
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 |
|---|---|---|
| Individual Meaning-Centered Psychotherapy (IMCP)IMCP is based on the principles of Viktor Frankl's Logotherapy, and is designed to help patients with advanced cancer sustain or enhance a sense of meaning, peace and purpose in their lives even as they approach the end of life. IMCP is structured as a 7-session (1-hour weekly sessions) individual intervention that utilizes a mixture of didactics, discussion and experiential exercises that focus around particular themes related to meaning and advanced cancer. In addition we will be asking patients in the IMCP arm to complete an optional weekly session rating survey | Behavioural | Individual Meaning-Centered Psychotherapy (IMCP) |
| standard Individual Supportive Psychotherapy (ISP)The ISP intervention utilized as the comparison treatment condition in this study, is adapted from the Supportive Group Psychotherapy manualized intervention developed by David Payne (1997) and adapted by Drs. Kissane, Breitbart and colleagues into the ISP manualized intervention. This intervention is a 7-session individual supportive psychotherapy utilizing an approach to supportive psychotherapy based on models described by Rogers. The essential components of supportive psychotherapy are integrated into this manualized intervention, including: reassurance, explanation, guidance, suggestion, encouragement, affecting changes in patient's environment, and permission for catharsis. | Behavioural | standard Individual Supportive Psychotherapy (ISP) |
| enhanced usual care (EUC)Also: Several referrals may be made based on identified problem areas, using the following guidelines:, • "Practical Problems" - Social Work on their disease management team, • "Family Problems"- Family Clinic at MSKCC Counseling Center, • "Emotional Problems" - MSKCC Counseling CenterWe are therefore including what we refer to as an "enhanced" usual care arm to this randomized controlled trial to address the ethical issues raised by utilizing a usual care condition in a vulnerable advanced cancer population. Participants will receive feedback about their level of distress (based on the DT administered at screening) and given appropriate targeted referrals based on levels of distress and problem areas endorsed. Participants will be given a letter with a list of appropriate referrals. | Behavioural | enhanced usual care (EUC) |
Primary outcome
Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R)
Time frame: baseline meaning making measures and again at post-intervention (approximately week 8)
The Life Attitude Profile-Revised (LAP-R) is a 48-item self-report measure of discovered meaning and purpose in life and the motivation to find meaning and purpose in life. There are 6 subscales: Purpose (8 items, Minimum 8, Maximum 56, Higher is better), Coherence (8 items, Minimum 8, Maximum 56, Higher is better), Life control (8 items, Minimum 8, Maximum 56, Higher is better), Death acceptance (8 items, Minimum 8, Maximum 56, Higher is better), Existential transcendence (16 items, Minimum 16, Maximum 112, Higher is better), Personal Meaning (16 items, Minimum 16, Maximum 112, Higher is better), Goal Seeking (8 items, Minimum 8, Maximum 56, Higher is better): LAP-R total score (48 items, Minimum 72, Maximum 504, Higher is better). The LAP-R total score is derived by summing all subscales.
3 secondary outcomes
Clinical and Demographic Variables That May Correspond to Differential Responses to Individual Meaning-Centered Psychotherapy
Time frame: baseline meaning making measures and again at post-intervention (approximately week 8)
The Relative Impact of Individual Meaning-Centered Psychotherapy on Different Aspects of Meaning (e.g., Purpose, Coherence, Existential Vacuum), as Well as on Different Aspects of Spiritual Well-being (Meaning Versus Faith),
Time frame: baseline meaning making measures and again at post-intervention (approximately week 8)
Whether an Enhanced Sense of Meaning "Explains" (Mediates) Improved Psychological Well-being (i.e., Increased Quality of Life, Decreased Psychological Distress).
Time frame: 4 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33732196Marziliano A, Applebaum A, Moyer A, Pessin H, Rosenfeld B, Breitbart W. The Impact of Matching to Psychotherapy Preference on Engagement in a Randomized Controlled Trial for Patients With Advanced Cancer. Front Psychol. 2021 Feb 24;12:637519. doi: 10.3389/fpsyg.2021.637519. eCollection 2021.
- Memorial Sloan Kettering Cancer CenterLink 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.
William Breitbart, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Solid Tumor Diseases, run by Memorial Sloan Kettering Cancer Center 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 11 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: finished, as of the sponsor's last update on 1 Jul 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?
Yes. Results are posted in the registry (first posted 1 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R) (time frame: baseline meaning making measures and again at post-intervention (approximately week 8)). 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 NCT01323309, which also lists 1 linked publication.
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 1 Jul 2024.