Advanced Solid Tumor Diseases
Conditions
Keywords
Supportive Psychotherapy, Therapy, 11-021
Brief 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. 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.
Interventions
BEHAVIORALIndividual 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
BEHAVIORALstandard 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.
BEHAVIORALenhanced 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.
Sponsors
National Cancer Institute (NCI)
Fordham University
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * 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.
Exclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical and Demographic Variables That May Correspond to Differential Responses to Individual Meaning-Centered Psychotherapy | 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. |
| 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), | 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. |
| Whether an Enhanced Sense of Meaning Explains (Mediates) Improved Psychological Well-being (i.e., Increased Quality of Life, Decreased Psychological Distress). | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 109 |
| 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. | 108 |
| 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. | 104 |
| Total | 321 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 9 | 15 | 5 |
| Overall Study | Disease progression | 5 | 11 | 4 |
| Overall Study | Lost to Follow-up | 11 | 14 | 24 |
| Overall Study | Withdrawal by Subject | 14 | 14 | 18 |
Baseline characteristics
| Characteristic | Total | Individual Meaning-Centered Psychotherapy (IMCP) | Standard Individual Supportive Psychotherapy (ISP) | Enhanced Usual Care (EUC) |
|---|---|---|---|---|
| Age, Continuous | 58.0 years | 58.1 years | 58.8 years | 57.1 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 30 Participants | 8 Participants | 8 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 289 Participants | 100 Participants | 100 Participants | 89 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 3 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 33 Participants | 15 Participants | 11 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 17 Participants | 4 Participants | 8 Participants | 5 Participants |
| Race (NIH/OMB) White | 260 Participants | 87 Participants | 85 Participants | 88 Participants |
| Region of Enrollment United States | 321 Participants | 109 Participants | 108 Participants | 104 Participants |
| Sex: Female, Male Female | 230 Participants | 81 Participants | 71 Participants | 78 Participants |
| Sex: Female, Male Male | 91 Participants | 28 Participants | 37 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 9 / 109 | 15 / 108 | 5 / 104 |
| other Total, other adverse events | 1 / 109 | 2 / 108 | 4 / 104 |
| serious Total, serious adverse events | 0 / 109 | 0 / 108 | 0 / 104 |
Outcome results
Primary
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.
Time frame: baseline meaning making measures and again at post-intervention (approximately week 8)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Individual Meaning-Centered Psychotherapy (IMCP) | 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 |
| Individual Meaning-Centered Psychotherapy (IMCP) | 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 |
| Individual Meaning-Centered Psychotherapy (IMCP) | 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 |
| Individual Meaning-Centered Psychotherapy (IMCP) | 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 |
| Individual Meaning-Centered Psychotherapy (IMCP) | 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 |
| Individual Meaning-Centered Psychotherapy (IMCP) | 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 |
| Individual Meaning-Centered Psychotherapy (IMCP) | 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 |
| Individual Meaning-Centered Psychotherapy (IMCP) | 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 |
| Standard Individual Supportive Psychotherapy (ISP) | Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R) | Coherence at Baseline | 38.73 scores on a scale | Standard Deviation 9.14 |
| Standard Individual Supportive Psychotherapy (ISP) | Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R) | Existential Transcendence at Baseline | 79.42 scores on a scale | Standard Deviation 32.99 |
| Standard Individual Supportive Psychotherapy (ISP) | Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R) | Coherence at Post-intervention | 41.39 scores on a scale | Standard Deviation 8.19 |
| Standard Individual Supportive Psychotherapy (ISP) | Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R) | Personal meaning at Baseline | 77.01 scores on a scale | Standard Deviation 15.95 |
| Standard Individual Supportive Psychotherapy (ISP) | Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R) | Personal meaning at Post-intervention | 92.48 scores on a scale | Standard Deviation 14.72 |
| Standard Individual Supportive Psychotherapy (ISP) | Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R) | Purpose at Baseline | 38.28 scores on a scale | Standard Deviation 8.25 |
| Standard Individual Supportive Psychotherapy (ISP) | Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R) | Purpose at Post-intervention | 41.09 scores on a scale | Standard Deviation 7.7 |
| Standard Individual Supportive Psychotherapy (ISP) | Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R) | Existential Transcendence at Post-intervention | 91.07 scores on a scale | Standard Deviation 31.24 |
| Enhanced Usual Care (EUC) | Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R) | Coherence at Baseline | 38.69 scores on a scale | Standard Deviation 8.29 |
| Enhanced Usual Care (EUC) | Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R) | Purpose at Post-intervention | 37.40 scores on a scale | Standard Deviation 7.78 |
| Enhanced Usual Care (EUC) | Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R) | Purpose at Baseline | 36.80 scores on a scale | Standard Deviation 9.11 |
| Enhanced Usual Care (EUC) | Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R) | Coherence at Post-intervention | 40.55 scores on a scale | Standard Deviation 8.6 |
| Enhanced Usual Care (EUC) | Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R) | Existential Transcendence at Baseline | 75.66 scores on a scale | Standard Deviation 30.26 |
| Enhanced Usual Care (EUC) | Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R) | Personal meaning at Post-intervention | 77.95 scores on a scale | Standard Deviation 14.96 |
| Enhanced Usual Care (EUC) | Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R) | Personal meaning at Baseline | 75.49 scores on a scale | Standard Deviation 16.26 |
| Enhanced Usual Care (EUC) | Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R) | Existential Transcendence at Post-intervention | 80.97 scores on a scale | Standard Deviation 30.8 |
Secondary
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.
Time frame: baseline meaning making measures and again at post-intervention (approximately week 8)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Individual Meaning-Centered Psychotherapy (IMCP) | 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 |
| Individual Meaning-Centered Psychotherapy (IMCP) | 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 |
| Standard Individual Supportive Psychotherapy (ISP) | Clinical and Demographic Variables That May Correspond to Differential Responses to Individual Meaning-Centered Psychotherapy | SWB Total Score at Baseline | 28.19 scores on a scale | Standard Deviation 9.31 |
| Standard Individual Supportive Psychotherapy (ISP) | Clinical and Demographic Variables That May Correspond to Differential Responses to Individual Meaning-Centered Psychotherapy | SWB Total Score at Post-intervention | 32.86 scores on a scale | Standard Deviation 8.9 |
| Enhanced Usual Care (EUC) | Clinical and Demographic Variables That May Correspond to Differential Responses to Individual Meaning-Centered Psychotherapy | SWB Total Score at Baseline | 29.53 scores on a scale | Standard Deviation 8.92 |
| Enhanced Usual Care (EUC) | Clinical and Demographic Variables That May Correspond to Differential Responses to Individual Meaning-Centered Psychotherapy | SWB Total Score at Post-intervention | 31.88 scores on a scale | Standard Deviation 8.28 |
Secondary
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.
Time frame: baseline meaning making measures and again at post-intervention (approximately week 8)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Individual Meaning-Centered Psychotherapy (IMCP) | 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 |
| Individual Meaning-Centered Psychotherapy (IMCP) | 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 |
| Individual Meaning-Centered Psychotherapy (IMCP) | 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 |
| Individual Meaning-Centered Psychotherapy (IMCP) | 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 |
| Individual Meaning-Centered Psychotherapy (IMCP) | 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 |
| Individual Meaning-Centered Psychotherapy (IMCP) | 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 |
| Individual Meaning-Centered Psychotherapy (IMCP) | 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 |
| Individual Meaning-Centered Psychotherapy (IMCP) | 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 |
| Standard Individual Supportive Psychotherapy (ISP) | 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 | 3.96 scores on a scale | Standard Deviation 2 |
| Standard Individual Supportive Psychotherapy (ISP) | 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 | 6.19 scores on a scale | Standard Deviation 1.55 |
| Standard Individual Supportive Psychotherapy (ISP) | 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 | 6.77 scores on a scale | Standard Deviation 1.71 |
| Standard Individual Supportive Psychotherapy (ISP) | 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 | 7.43 scores on a scale | Standard Deviation 1.82 |
| Standard Individual Supportive Psychotherapy (ISP) | 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 | 7.43 scores on a scale | Standard Deviation 1.82 |
| Standard Individual Supportive Psychotherapy (ISP) | 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 | 3.61 scores on a scale | Standard Deviation 2.04 |
| Standard Individual Supportive Psychotherapy (ISP) | 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 | 6.77 scores on a scale | Standard Deviation 1.71 |
| Standard Individual Supportive Psychotherapy (ISP) | 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 | 6.55 scores on a scale | Standard Deviation 1.59 |
| Enhanced Usual Care (EUC) | 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 | 7.22 scores on a scale | Standard Deviation 1.63 |
| Enhanced Usual Care (EUC) | 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 | 6.24 scores on a scale | Standard Deviation 1.58 |
| Enhanced Usual Care (EUC) | 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 | 6.49 scores on a scale | Standard Deviation 1.47 |
| Enhanced Usual Care (EUC) | 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 | 3.53 scores on a scale | Standard Deviation 2.18 |
| Enhanced Usual Care (EUC) | 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 | 3.58 scores on a scale | Standard Deviation 1.96 |
| Enhanced Usual Care (EUC) | 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 | 6.78 scores on a scale | Standard Deviation 1.74 |
| Enhanced Usual Care (EUC) | 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 | 7.22 scores on a scale | Standard Deviation 1.63 |
| Enhanced Usual Care (EUC) | 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 | 6.78 scores on a scale | Standard Deviation 1.74 |
Secondary
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).
Time frame: 4 years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Individual Meaning-Centered Psychotherapy (IMCP) | 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 |
| Individual Meaning-Centered Psychotherapy (IMCP) | 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 |
| Standard Individual Supportive Psychotherapy (ISP) | 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 | 2.95 scores on a scale | Standard Deviation 3.12 |
| Standard Individual Supportive Psychotherapy (ISP) | 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 | 2.62 scores on a scale | Standard Deviation 2.92 |
| Enhanced Usual Care (EUC) | 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 | 2.19 scores on a scale | Standard Deviation 2.33 |
| Enhanced Usual Care (EUC) | 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 | 2.05 scores on a scale | Standard Deviation 3.09 |