Trial Outcomes & Findings for Trial of Individual Psychosocial Interventions for Cancer Patients (NCT NCT01323309)

Last Updated: 2024-07-01

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

346 participants

Primary outcome timeframe

baseline meaning making measures and again at post-intervention (approximately week 8)

Results posted on

2024-07-01

Participant Flow

Participant milestones

Participant milestones
Measure	Individual Meaning-Centered Psychotherapy (IMCP) 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	Standard Individual Supportive Psychotherapy (ISP) 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.	Enhanced Usual Care (EUC) enhanced usual care (EUC): 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.
Overall Study STARTED	109	108	104
Overall Study COMPLETED	70	54	53
Overall Study NOT COMPLETED	39	54	51

Reasons for withdrawal

Reasons for withdrawal
Measure	Individual Meaning-Centered Psychotherapy (IMCP) 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	Standard Individual Supportive Psychotherapy (ISP) 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.	Enhanced Usual Care (EUC) enhanced usual care (EUC): 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.
Overall Study Death	9	15	5
Overall Study Lost to Follow-up	11	14	24
Overall Study Withdrawal by Subject	14	14	18
Overall Study Disease progression	5	11	4

Baseline Characteristics

Trial of Individual Psychosocial Interventions for Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Individual Meaning-Centered Psychotherapy (IMCP) n=109 Participants 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	Standard Individual Supportive Psychotherapy (ISP) n=108 Participants 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.	Enhanced Usual Care (EUC) n=104 Participants enhanced usual care (EUC): 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.	Total n=321 Participants Total of all reporting groups
Age, Continuous	58.1 years n=5 Participants	58.8 years n=7 Participants	57.1 years n=5 Participants	58.0 years n=4 Participants
Sex: Female, Male Female	81 Participants n=5 Participants	71 Participants n=7 Participants	78 Participants n=5 Participants	230 Participants n=4 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	37 Participants n=7 Participants	26 Participants n=5 Participants	91 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants	30 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	100 Participants n=5 Participants	100 Participants n=7 Participants	89 Participants n=5 Participants	289 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	11 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	11 Participants n=7 Participants	7 Participants n=5 Participants	33 Participants n=4 Participants
Race (NIH/OMB) White	87 Participants n=5 Participants	85 Participants n=7 Participants	88 Participants n=5 Participants	260 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	17 Participants n=4 Participants
Region of Enrollment United States	109 Participants n=5 Participants	108 Participants n=7 Participants	104 Participants n=5 Participants	321 Participants n=4 Participants

PRIMARY outcome

Timeframe: baseline meaning making measures and again at post-intervention (approximately week 8)

Outcome measures

Outcome measures
Measure	Individual Meaning-Centered Psychotherapy (IMCP) n=94 Participants 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	Standard Individual Supportive Psychotherapy (ISP) n=86 Participants 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.	Enhanced Usual Care (EUC) n=74 Participants enhanced usual care (EUC): 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.
Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R) Purpose at Post-intervention	42.22 scores on a scale Standard Deviation 8.77	41.09 scores on a scale Standard Deviation 7.70	37.40 scores on a scale Standard Deviation 7.78
Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R) Personal meaning at Post-intervention	85.82 scores on a scale Standard Deviation 16.84	92.48 scores on a scale Standard Deviation 14.72	77.95 scores on a scale Standard Deviation 14.96
Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R) Purpose at Baseline	37.07 scores on a scale Standard Deviation 9.33	38.28 scores on a scale Standard Deviation 8.25	36.80 scores on a scale Standard Deviation 9.11
Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R) Coherence at Baseline	37.67 scores on a scale Standard Deviation 9.97	38.73 scores on a scale Standard Deviation 9.14	38.69 scores on a scale Standard Deviation 8.29
Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R) Coherence at Post-intervention	43.60 scores on a scale Standard Deviation 8.86	41.39 scores on a scale Standard Deviation 8.19	40.55 scores on a scale Standard Deviation 8.60
Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R) Personal meaning at Baseline	74.74 scores on a scale Standard Deviation 18.03	77.01 scores on a scale Standard Deviation 15.95	75.49 scores on a scale Standard Deviation 16.26
Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R) Existential Transcendence at Baseline	78.27 scores on a scale Standard Deviation 33.14	79.42 scores on a scale Standard Deviation 32.99	75.66 scores on a scale Standard Deviation 30.26
Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R) Existential Transcendence at Post-intervention	102.27 scores on a scale Standard Deviation 33.14	91.07 scores on a scale Standard Deviation 31.24	80.97 scores on a scale Standard Deviation 30.80

SECONDARY outcome

Timeframe: baseline meaning making measures and again at post-intervention (approximately week 8)

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.

Outcome measures

Outcome measures
Measure	Individual Meaning-Centered Psychotherapy (IMCP) n=109 Participants 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	Standard Individual Supportive Psychotherapy (ISP) n=108 Participants 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.	Enhanced Usual Care (EUC) n=104 Participants enhanced usual care (EUC): 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.
Clinical and Demographic Variables That May Correspond to Differential Responses to Individual Meaning-Centered Psychotherapy SWB Total Score at Baseline	28.48 scores on a scale Standard Deviation 10.43	28.19 scores on a scale Standard Deviation 9.31	29.53 scores on a scale Standard Deviation 8.92
Clinical and Demographic Variables That May Correspond to Differential Responses to Individual Meaning-Centered Psychotherapy SWB Total Score at Post-intervention	34.59 scores on a scale Standard Deviation 9.39	32.86 scores on a scale Standard Deviation 8.90	31.88 scores on a scale Standard Deviation 8.28

SECONDARY outcome

Timeframe: baseline meaning making measures and again at post-intervention (approximately week 8)

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.

Outcome measures

Outcome measures
Measure	Individual Meaning-Centered Psychotherapy (IMCP) n=109 Participants 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	Standard Individual Supportive Psychotherapy (ISP) n=108 Participants 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.	Enhanced Usual Care (EUC) n=104 Participants enhanced usual care (EUC): 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.
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), MQOL: Physical symptoms at Baseline	3.73 scores on a scale Standard Deviation 2.06	3.96 scores on a scale Standard Deviation 2.00	3.53 scores on a scale Standard Deviation 2.18
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), MQOL: Physical symptoms at Post-intervention	3.76 scores on a scale Standard Deviation 2.17	3.61 scores on a scale Standard Deviation 2.04	3.58 scores on a scale Standard Deviation 1.96
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), Psychological at Baseline	6.43 scores on a scale Standard Deviation 1.75	6.77 scores on a scale Standard Deviation 1.71	6.78 scores on a scale Standard Deviation 1.74
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), Psychological at Post-intervention	8.08 scores on a scale Standard Deviation 1.61	7.43 scores on a scale Standard Deviation 1.82	7.22 scores on a scale Standard Deviation 1.63
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), Existential at Baseline	6.71 scores on a scale Standard Deviation 1.75	6.77 scores on a scale Standard Deviation 1.71	6.78 scores on a scale Standard Deviation 1.74
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), Existential at Post-intervention	8.08 scores on a scale Standard Deviation 1.61	7.43 scores on a scale Standard Deviation 1.82	7.22 scores on a scale Standard Deviation 1.63
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), Overall at Baseline	6.29 scores on a scale Standard Deviation 1.49	6.19 scores on a scale Standard Deviation 1.55	6.24 scores on a scale Standard Deviation 1.58
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), Overall at Post-intervention	7.33 scores on a scale Standard Deviation 1.75	6.55 scores on a scale Standard Deviation 1.59	6.49 scores on a scale Standard Deviation 1.47

SECONDARY outcome

Timeframe: 4 years

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).

Outcome measures

Outcome measures
Measure	Individual Meaning-Centered Psychotherapy (IMCP) n=109 Participants 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	Standard Individual Supportive Psychotherapy (ISP) n=108 Participants 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.	Enhanced Usual Care (EUC) n=104 Participants enhanced usual care (EUC): 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.
Whether an Enhanced Sense of Meaning "Explains" (Mediates) Improved Psychological Well-being (i.e., Increased Quality of Life, Decreased Psychological Distress). SAHD Total Scores at Baseline	2.89 scores on a scale Standard Deviation 3.16	2.95 scores on a scale Standard Deviation 3.12	2.19 scores on a scale Standard Deviation 2.33
Whether an Enhanced Sense of Meaning "Explains" (Mediates) Improved Psychological Well-being (i.e., Increased Quality of Life, Decreased Psychological Distress). SAHD Total Scores at Post-intervention	1.97 scores on a scale Standard Deviation 2.26	2.62 scores on a scale Standard Deviation 2.92	2.05 scores on a scale Standard Deviation 3.09

Adverse Events

Individual Meaning-Centered Psychotherapy (IMCP)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 9 deaths

Standard Individual Supportive Psychotherapy (ISP)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 15 deaths

Enhanced Usual Care (EUC)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 5 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Individual Meaning-Centered Psychotherapy (IMCP) n=109 participants at risk 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	Standard Individual Supportive Psychotherapy (ISP) n=108 participants at risk 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.	Enhanced Usual Care (EUC) n=104 participants at risk enhanced usual care (EUC): 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.
General disorders Distress during assessment	0.92% 1/109 • 8 weeks	1.9% 2/108 • 8 weeks	3.8% 4/104 • 8 weeks
Psychiatric disorders Suicidal ideation	0.92% 1/109 • 8 weeks	0.00% 0/108 • 8 weeks	0.00% 0/104 • 8 weeks

Additional Information

Dr. William Breitbart, MD

Memorial Sloan Kettering Cancer Center

Phone: 646-888-0020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place